Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT01990768
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2013-10-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prehospital Tranexamic Acid Use for Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rochelp@uwctc.org', 'phone': '206-685-1302', 'title': 'Dr. Susanne May', 'organization': 'University of Washington, Resuscitation Outcomes Consortium'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators.', 'description': 'Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.', 'otherNumAtRisk': 309, 'deathsNumAtRisk': 309, 'otherNumAffected': 81, 'seriousNumAtRisk': 309, 'deathsNumAffected': 50, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.', 'otherNumAtRisk': 312, 'deathsNumAtRisk': 312, 'otherNumAffected': 74, 'seriousNumAtRisk': 312, 'deathsNumAffected': 53, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.', 'otherNumAtRisk': 345, 'deathsNumAtRisk': 345, 'otherNumAffected': 92, 'seriousNumAtRisk': 345, 'deathsNumAffected': 40, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Cardiac arrest (non-fatal)^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction (MI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudomembranous colitis^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Compartment Syndrome^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Central diabetes insipidus^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral vasospams^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extremity Compartment Syndrome^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver failure^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloodstream infection^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Empyema^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra-abdominal abscess^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection (UTI)^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatremia^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident - hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident - thrombotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury (AKI)^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Respiratory Distress Syndrome (ARDS)^', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism (PE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral venus sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein throbosis (DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial venus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction (MI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident - hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident - thrombotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism (PE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral vascular emboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral venus sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis (DVT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolic infarcts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inferior vena cava thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Internal jugular vein thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 345, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '657', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG003', 'title': 'Combined TXA Arms', 'description': 'Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.'}], 'classes': [{'categories': [{'title': 'Unfavorable GOS-E (<=4)', 'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}, {'title': 'Favorable GOS-E (>4)', 'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '331', 'groupId': 'OG003'}]}, {'title': 'Missing GOS-E', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.1809', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '0.87', 'pValueComment': 'Based on an interim futility analysis, a one-sided P-value less than .1028 was required to declare benefit.', 'estimateComment': 'Odds ratio for unfavorable GOS-E (\\<=4) for the Combined TXA Arms (numerator) vs. Placebo (denominator)', 'groupDescription': 'This study was designed with an asymmetric boundary for tests for treatment harm and benefit. The conventional 0.025 level was used to test for harm while a 0.1 level was used to determine benefit for this Phase II trial. Statistical significance for the primary analysis was conducted under a group-sequential design that included a single, interim futility analysis using a Wang-Tsiatis boundary with parameter 0.8 based on outcome data from the first 200 subjects.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis was adjusted for regional site. Missing outcomes were multiply imputed.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-injury', 'description': 'GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Within 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '318', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days after hospital arrival', 'description': 'The counts of patients who died on or before day 28 are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started and 28-day vital status was definitively obtained. Patients excluded from the counts include subjects who withdrew from the study prior to day 28 and subjects who were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Disability Rating Scale (DRS) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '10.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post-injury', 'description': 'The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started and DRS questions were obtained at 6 months. Excluded subjects include those who withdrew prior to 6 months after injury and those lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Unfavorable Outcome on Dichotomized Glasgow Outcome Scale Extended (GOS-E) at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the end of the hospital stay (average of 9 days post injury)', 'description': 'GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes. The number of subjects with unfavorable outcome is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started and for whom Glasgow Outcome Score Extended was obtained at discharge. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Disability Rating Scale (DRS) at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '9.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the end of the hospital stay (average of 9 days post injury)', 'description': 'The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started and for whom discharge Disability Rating Scale was obtained. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intracranial Hemorrhage (ICH) Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 13 days among patients with multiple scans)', 'description': 'All clinically indicated head computed tomography (CT) scans obtained during the initial hospitalization or within the first 28 days were assessed for ICH. Parenchymal (IPH), subdural (SDH) and epidural (EDH) hemorrhage volumes were measured and quantified using volumetric software and verified by manual calculations based on the previously validated ABC/2 technique. The sum of the IPH, SDH, and EDH volumes were compared across scans. A relative increase of 33% (and at least a 1 ml increase) on any subsequent scan compared to the initial scan was defined as a progression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started and for whom two or more analyzable head CT scans were obtained prior to a hematoma evacuation. Excluded subjects primarily include those who died or withdrew before an initial or second CT scan was taken, who had a hematoma evacuation prior to a second scan, or who had only one negative CT.'}, {'type': 'SECONDARY', 'title': 'Marshall Computed Tomography (CT) Score on Initial Head CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'title': 'Diffuse injury I', 'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}, {'title': 'Diffuse injury II', 'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}, {'title': 'Diffuse injury III', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'Diffuse injury IV', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Mass lesion V/VI', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial head CT (average of 1.9 hours post-injury)', 'description': 'The Marshall classification categorizes patients into one of six categories (I to VI) of increasing severity on the basis of findings on non-contrast CT scan of the brain. Higher categories have worse prognosis and survival.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received an initial head computed tomography scan with sufficient information to be scored.'}, {'type': 'SECONDARY', 'title': 'Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': '2', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}, {'title': '3', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}, {'title': '4', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}, {'title': '5', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}, {'title': '6', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial head CT (average of 1.9 hours post-injury)', 'description': 'The Rotterdam classification includes four independently scored elements: degree of basal cistern compression, degree of midline shift, presence of epidural hematomas, and presence of intraventricular or subarachnoid blood. The elements are combined to form an overall score from 1 to 6 with higher scores having worse prognosis and survival.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects determined by the central image reviewer to have an intracranial hemorrhage (ICH) on the initial head computed tomography (CT) scan and sufficient information to assign the Rotterdam score.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Neurosurgical Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Neurosurgical interventions include craniotomy, craniectomy, and placement of a neuromonitoring or drainage device. Counts are of subjects with one or more neurosurgical interventions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}, {'type': 'SECONDARY', 'title': 'Hospital-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '331', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '14.1', 'spread': '10.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From hospital admission through day 28', 'description': 'Hospital-free days count any day from hospital admission through day 28 that the patient is alive and out of the hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started and for whom discharge status was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit (ICU)-Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '331', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '19.1', 'spread': '9.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From hospital admission through day 28', 'description': 'ICU-free days count any day from hospital admission through day 28 that the patient is alive and not in the ICU. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started and for whom number of ICU days through 28 days was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '331', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '20.9', 'spread': '9.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From hospital admission through day 28', 'description': 'Ventilator-free days count any day from hospital admission through day 28 that the patient is alive and does not require mechanical ventilatory support. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started and for whom number of ventilator days through 28 days was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Seizure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug infusion through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Seizures may cause involuntary changes in body movement or function, sensation, awareness, or behavior. Seizures are often associated with a sudden and involuntary contraction of a group of muscles and loss of consciousness. Seizures or episodes of seizure-like activity were reported by medics in the field following the start of study drug infusion through hand-off to the trauma center and by trauma center staff through discharge. Reported events were included if providers gave anti-seizure medication and/or the event was confirmed by EEG.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cerebral Ischemic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of cerebral ischemic event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial Infarction (MI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of an acute myocardial infarction', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Deep Vein Thrombosis (DVT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of DVT', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pulmonary Embolus (PE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of PE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Thromboembolic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of one or more of the following: cerebral ischemic event, myocardial infarction (MI), deep vein thrombosis (DVT), pulmonary embolism (PE), or any other thromboembolic event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fibrinolysis at Hospital Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'OG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'classes': [{'categories': [{'title': '<0.8 (fibrinolysis shutdown)', 'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}, {'title': '0.8-3% (normal)', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}, {'title': '>3% (hyperfibrinolysis)', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First blood draw (average of 1.6 hours post-injury)', 'description': 'Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on kaolin-activated thromboelastography (TEG) and defined as LY30 or the per cent lysis that occurs 30 minutes after maximum amplitude (MA) is achieved. LY30 is categorized as \\<0.8% (fibrinolysis shutdown), 0.8-3% (normal), and \\>3% (hyperfibrinolysis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with an LY30 measurement at hospital admission are included. Subjects who were transported to trauma centers without a TEG machine, who died prior to the initial blood draw, or who withdrew or refused a blood draw were excluded. Additional exclusions included blood draw missed by study staff and technical difficulties with processing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'FG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'FG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}], 'periods': [{'title': 'Intervention Started', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '345'}, {'groupId': 'FG001', 'numSubjects': '345'}, {'groupId': 'FG002', 'numSubjects': '373'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '346'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Found to be ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Study drug issue or kit malfunction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Patient became ineligible due to vitals', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Not enough time for EMS to enroll', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient care priority', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'IV lost', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Required CPR', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Seizure or hx of seizure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Discovered to be pregnant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Prehospital Study Drug Infusion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '346'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}, {'groupId': 'FG001', 'numSubjects': '285'}, {'groupId': 'FG002', 'numSubjects': '327'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Protocol non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Seizure or concern for seizure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Required CPR', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other safety concern', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Discharged', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Emergency unblinding', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Unknown if completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'In-Hospital Study Drug Infusion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '346'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '229'}, {'groupId': 'FG002', 'numSubjects': '266'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '80'}]}], 'dropWithdraws': [{'type': 'Discharged', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Protocol non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Death or comfort care', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Emergency unblinding', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Seizure or concern for seizure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'CVA/thrombotic event or concern for one', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Required CPR', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other safety concern', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Taken into police custody', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Found not to be injured', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Transfer to non-participating facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other procoagulant administered', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Unknown if completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': '6-Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '346'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '261'}, {'groupId': 'FG002', 'numSubjects': '288'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'Calls unreturned or refused contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'No contact information', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Homeless', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Prisoner at time of enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Prisoner at time of follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient at psychiatric hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between May 2015 and March 2017, participants were enrolled by 39 emergency management service (EMS) agencies and transported to 20 trauma centers within 12 regional sites in North America.', 'preAssignmentDetails': 'Some persons for whom the blinded study kit was opened did not actually receive any of the study drug. These persons are not included in the enrollment numbers. However, they are enumerated in the first section of the patient flow tables.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'BG001', 'title': 'Bolus-Maintenance', 'description': '1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'BG002', 'title': 'Bolus Only', 'description': '2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '55'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '57'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '56'}, {'value': '38', 'groupId': 'BG003', 'lowerLimit': '25', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}, {'value': '715', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}, {'value': '700', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity was not reported at Canadian sites.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}, {'value': '642', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race was not reported at Canadian sites.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '878', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Penetrating injury', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cause of injury', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}, {'value': '960', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Motor vehicle occupant', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}, {'title': 'Motor vehicle motorcycle', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}, {'title': 'Motor vehicle bicycle/pedestrian', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}, {'title': 'Fall at ground level', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}, {'title': 'Fall at more than 1 meter', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}, {'title': 'Assault', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}, {'title': 'Suicide', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Cause of injury missing on 1 placebo participant and 5 bolus only participants.'}, {'title': 'Prehospital Glasgow Coma Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}], 'categories': [{'title': '3-8', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '532', 'groupId': 'BG003'}]}, {'title': '9-12', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '403', 'groupId': 'BG003'}]}, {'title': '13-15', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Neurological scale used to assess the level of consciousness following traumatic brain injury. Scores range from 3 to 15. Scores of 3-8 are generally considered severe, 9-12 moderate, and 13-15 minor.', 'unitOfMeasure': 'Participants'}, {'title': 'Injury Severity Score (ISS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}, {'value': '948', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '27'}, {'value': '17', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '27'}, {'value': '17', 'groupId': 'BG002', 'lowerLimit': '8', 'upperLimit': '27'}, {'value': '17', 'groupId': 'BG003', 'lowerLimit': '9', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Injury Severity Score is a measure used to assess trauma severity. It is correlated with mortality, morbidity, and hospital length of stay. The score ranges between 0 (no injury) and 75 (unsurvivable injury). Scores greater than 15 are defined as major trauma.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'ISS is sometimes not available if the patient dies early or there is insufficient information about injuries in specific body regions. The measure is missing for 7 placebo, 8 bolus-maintenance, and 3 bolus only participants.'}, {'title': 'Head Abbreviated Injury Score (AIS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}, {'value': '951', 'groupId': 'BG003'}]}], 'categories': [{'title': '0-1', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}, {'title': '2', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}, {'title': '3', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}]}, {'title': '4', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}, {'title': '5-6', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Abbreviated Injury Scale is an anatomical-based coding system used to classify and describe the severity of injuries. The scores for a particular region range from 0 (no injury) to 6 (unsurvivable injury).', 'unitOfMeasure': 'Participants', 'populationDescription': 'Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.'}], 'populationDescription': 'Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-03', 'size': 607794, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol in force at beginning of enrollment', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-07-26T13:20', 'hasProtocol': True}, {'date': '2015-07-29', 'size': 609419, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol after Amendment 2', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-07-26T13:23', 'hasProtocol': True}, {'date': '2016-08-02', 'size': 609150, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol after Amendment 2.1', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_002.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-07-26T13:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 967}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-31', 'studyFirstSubmitDate': '2013-10-30', 'resultsFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2013-11-15', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-31', 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fibrinolysis at Hospital Admission', 'timeFrame': 'First blood draw (average of 1.6 hours post-injury)', 'description': 'Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on kaolin-activated thromboelastography (TEG) and defined as LY30 or the per cent lysis that occurs 30 minutes after maximum amplitude (MA) is achieved. LY30 is categorized as \\<0.8% (fibrinolysis shutdown), 0.8-3% (normal), and \\>3% (hyperfibrinolysis).'}], 'primaryOutcomes': [{'measure': 'Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months', 'timeFrame': '6 months post-injury', 'description': 'GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Died Within 28 Days', 'timeFrame': '28 days after hospital arrival', 'description': 'The counts of patients who died on or before day 28 are reported.'}, {'measure': 'Disability Rating Scale (DRS) at 6 Months', 'timeFrame': '6 months post-injury', 'description': 'The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).'}, {'measure': 'Number of Participants With Unfavorable Outcome on Dichotomized Glasgow Outcome Scale Extended (GOS-E) at Discharge', 'timeFrame': 'At the end of the hospital stay (average of 9 days post injury)', 'description': 'GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes. The number of subjects with unfavorable outcome is reported.'}, {'measure': 'Disability Rating Scale (DRS) at Discharge', 'timeFrame': 'At the end of the hospital stay (average of 9 days post injury)', 'description': 'The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).'}, {'measure': 'Number of Participants With Intracranial Hemorrhage (ICH) Progression', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 13 days among patients with multiple scans)', 'description': 'All clinically indicated head computed tomography (CT) scans obtained during the initial hospitalization or within the first 28 days were assessed for ICH. Parenchymal (IPH), subdural (SDH) and epidural (EDH) hemorrhage volumes were measured and quantified using volumetric software and verified by manual calculations based on the previously validated ABC/2 technique. The sum of the IPH, SDH, and EDH volumes were compared across scans. A relative increase of 33% (and at least a 1 ml increase) on any subsequent scan compared to the initial scan was defined as a progression.'}, {'measure': 'Marshall Computed Tomography (CT) Score on Initial Head CT', 'timeFrame': 'Initial head CT (average of 1.9 hours post-injury)', 'description': 'The Marshall classification categorizes patients into one of six categories (I to VI) of increasing severity on the basis of findings on non-contrast CT scan of the brain. Higher categories have worse prognosis and survival.'}, {'measure': 'Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT', 'timeFrame': 'Initial head CT (average of 1.9 hours post-injury)', 'description': 'The Rotterdam classification includes four independently scored elements: degree of basal cistern compression, degree of midline shift, presence of epidural hematomas, and presence of intraventricular or subarachnoid blood. The elements are combined to form an overall score from 1 to 6 with higher scores having worse prognosis and survival.'}, {'measure': 'Number of Participants With One or More Neurosurgical Interventions', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Neurosurgical interventions include craniotomy, craniectomy, and placement of a neuromonitoring or drainage device. Counts are of subjects with one or more neurosurgical interventions.'}, {'measure': 'Hospital-free Days', 'timeFrame': 'From hospital admission through day 28', 'description': 'Hospital-free days count any day from hospital admission through day 28 that the patient is alive and out of the hospital.'}, {'measure': 'Intensive Care Unit (ICU)-Free Days', 'timeFrame': 'From hospital admission through day 28', 'description': 'ICU-free days count any day from hospital admission through day 28 that the patient is alive and not in the ICU. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.'}, {'measure': 'Ventilator-free Days', 'timeFrame': 'From hospital admission through day 28', 'description': 'Ventilator-free days count any day from hospital admission through day 28 that the patient is alive and does not require mechanical ventilatory support. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.'}, {'measure': 'Number of Participants With Seizure', 'timeFrame': 'From start of study drug infusion through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Seizures may cause involuntary changes in body movement or function, sensation, awareness, or behavior. Seizures are often associated with a sudden and involuntary contraction of a group of muscles and loss of consciousness. Seizures or episodes of seizure-like activity were reported by medics in the field following the start of study drug infusion through hand-off to the trauma center and by trauma center staff through discharge. Reported events were included if providers gave anti-seizure medication and/or the event was confirmed by EEG.'}, {'measure': 'Number of Participants With Cerebral Ischemic Event', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of cerebral ischemic event'}, {'measure': 'Number of Participants With Myocardial Infarction (MI)', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of an acute myocardial infarction'}, {'measure': 'Number of Participants With Deep Vein Thrombosis (DVT)', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of DVT'}, {'measure': 'Number of Participants With Pulmonary Embolus (PE)', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of PE'}, {'measure': 'Number of Participants With Any Thromboembolic Event', 'timeFrame': 'From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)', 'description': 'Diagnosis of one or more of the following: cerebral ischemic event, myocardial infarction (MI), deep vein thrombosis (DVT), pulmonary embolism (PE), or any other thromboembolic event'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tranexamic acid', 'traumatic brain injury', 'intracranial hemorrhage', 'prehospital', 'neurologic outcome', 'glasgow outcome scale extended', 'disability rating scale'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '38685481', 'type': 'DERIVED', 'citation': 'Rowell S, Meier EN, Hoyos Gomez T, Fleming M, Jui J, Morrison L, Bulger E, Sopko G, Weisfeldt M, Christenson J, Klotz P, McMullan J, Callum J, Sheehan K, Tibbs B, Aufderheide T, Cotton B, Gandhi R, Idris A, Frascone RJ, Ferrara M, Richmond N, Kannas D, Schlamp R, Robinson B, Dries D, Tallon J, Hendrickson A, Gamber M, Garrett J, Simonson R, McKinley WI, Schreiber M. The effects of prehospital TXA on mortality and neurologic outcomes in patients with traumatic intracranial hemorrhage: A subgroup analysis from the prehospital TXA for TBI trial. J Trauma Acute Care Surg. 2024 Oct 1;97(4):572-580. doi: 10.1097/TA.0000000000004354. Epub 2024 Apr 30.'}, {'pmid': '37807179', 'type': 'DERIVED', 'citation': 'Hoefer LE, Benjamin AJ, Polcari AM, Schreiber MA, Zakrison TL, Rowell SE. TXA does not affect levels of TBI-related biomarkers in blunt TBI with ICH: A secondary analysis of the prehospital TXA for TBI trial. J Trauma Acute Care Surg. 2024 Jan 1;96(1):94-100. doi: 10.1097/TA.0000000000004130. Epub 2023 Oct 9.'}, {'pmid': '35358154', 'type': 'DERIVED', 'citation': 'Harmer JW, Dewey EN, Meier EN, Rowell SE, Schreiber MA. Tranexamic acid is not inferior to placebo with respect to adverse events in suspected traumatic brain injury patients not in shock with a normal head computed tomography scan: A retrospective study of a randomized trial. J Trauma Acute Care Surg. 2022 Jul 1;93(1):98-105. doi: 10.1097/TA.0000000000003635. Epub 2022 Mar 28.'}, {'pmid': '32897344', 'type': 'DERIVED', 'citation': 'Rowell SE, Meier EN, McKnight B, Kannas D, May S, Sheehan K, Bulger EM, Idris AH, Christenson J, Morrison LJ, Frascone RJ, Bosarge PL, Colella MR, Johannigman J, Cotton BA, Callum J, McMullan J, Dries DJ, Tibbs B, Richmond NJ, Weisfeldt ML, Tallon JM, Garrett JS, Zielinski MD, Aufderheide TP, Gandhi RR, Schlamp R, Robinson BRH, Jui J, Klein L, Rizoli S, Gamber M, Fleming M, Hwang J, Vincent LE, Williams C, Hendrickson A, Simonson R, Klotz P, Sopko G, Witham W, Ferrara M, Schreiber MA. Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury. JAMA. 2020 Sep 8;324(10):961-974. doi: 10.1001/jama.2020.8958.'}]}, 'descriptionModule': {'briefSummary': 'Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12).\n\nPrimary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to severe TBI will not change the proportion of patients with a favorable long-term neurologic outcome compared to random assignment to placebo, based on the GOS-E at 6 months.\n\nSecondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing regimens of TXA:\n\n* Clinical outcomes: ICH progression, Marshall and Rotterdam CT classification scores, DRS at discharge and 6 months, GOS-E at discharge, 28-day survival, frequency of neurosurgical interventions, and ventilator-free, ICU-free, and hospital-free days.\n* Safety outcomes: Development of seizures, cerebral ischemic events, myocardial infarction, deep venous thrombosis, and pulmonary thromboembolism.\n* Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on TEG.\n\nInclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg, prehospital intravenous (IV) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown), EMS transport destination based on standard local practices determined to be a participating trauma center.\n\nExclusion: Prehospital GCS=3 with no reactive pupil, estimated time from injury to start of study drug bolus dose \\>2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity, acute MI or stroke or known history, to the extent possible, of seizures, thromboembolic disorders or renal dialysis, CPR by EMS prior to randomization, burns \\> 20% TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA or other pro-coagulant drug given prior to randomization, subjects who have activated the "opt-out" process when required by the local regulatory board.\n\nA multi-center double-blind randomized controlled trial with 3 treatment arms:\n\n* Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.\n* Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.\n* Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.', 'detailedDescription': '1. Overview This multi-center, Phase II trial is designed to determine if Tranexamic Acid (TXA) initiated in the prehospital setting improves long-term neurologic outcome compared to placebo in patients with moderate to severe TBI who are not in shock. This study protocol will be conducted as part of the Resuscitation Outcomes Consortium (ROC) at trauma centers in the United States and Canada. ROC is funded by the National Heart Lung and Blood Institute (NHLBI) in partnership with the US Army Medical Research and Materiel Command (USAMRMC), Canadian Institutes of Health Research, the Heart \\& Stroke Foundation of Canada, the American Heart Association (AHA), and the Defense Research and Development Canada. ROC is a clinical trials network focusing on research primarily in the area of prehospital cardiopulmonary arrest and severe traumatic injury. The mission of ROC is to provide infrastructure and project support for clinical trials and other outcome-oriented research in the areas of cardiopulmonary arrest and severe traumatic injury that lead to evidence-based change in clinical practice.\n2. Specific Aims/Hypothesis Statement\n\n 2.1 Clinical Hypotheses and Aims\n\n Specific aim 1: To compare 6-month neurologic outcome between subjects who are randomly assigned to TXA to subjects who are randomly assigned to placebo by evaluating the Glasgow Outcome Scale Extended score (GOS-E) at 6 months post-injury.\n\n Primary Hypotheses: We will perform a one-sided test of the following null hypothesis: The proportion of subjects who have a favorable neurologic outcome (GOS-E \\> 4) at six months post injury who are randomly assigned to TXA is not different from the proportion of subjects who have a favorable neurologic outcome (GOS-E \\> 4) who are randomly assigned to placebo. This hypothesis will be tested versus the alternative that the proportion of subjects with a favorable neurologic outcome who are randomly assigned to TXA is higher than in subjects who are randomly assigned to placebo at the .1 level and versus the alternative that the proportion of subjects with a favorable neurologic outcome who are randomly assigned to TXA is lower than it is in the placebo group at the .025 level\n\n Specific aim 2: To assess differences in morbidity and mortality measured from randomization through 28 days or initial hospital discharge and differences in neurologic outcomes at 6 months between subjects in the bolus/maintenance arm, bolus only arm, and placebo arm.\n\n Secondary Hypotheses: The null hypotheses are that there will be no difference between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo in the following: both absolute and relative volume of intracranial hemorrhage (ICH) progression, proportion of subjects with ICH progression, frequency of neurosurgical interventions, GOS-E measured at discharge and 6 months, Disability Rating Scale score (DRS) measured at discharge and 6 months, 28-day survival, and ventilator-free, intensive care unit (ICU)-free, and hospital-free days.\n\n Specific aim 3: To assess differences in adverse events measured from randomization to initial hospital discharge between subjects in the bolus/maintenance arm, bolus only arm, and placebo arm.\n\n Tertiary Hypotheses: The null hypotheses are that there will be no difference between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo in the following: proportion of subjects experiencing seizures, cerebral ischemic events, myocardial infarction (MI), deep venous thrombosis (DVT), or pulmonary thromboembolism (PE) post randomization through 28 days or discharge, whichever occurs first.\n\n 2.2 Laboratory Hypotheses and Aims\n\n Specific aim 1: To compare coagulation profiles over time using kaolin activated thrombelastography (TEG) results between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo.\n\n Primary hypothesis: The null hypothesis is that there will be no difference in the degree of fibrinolysis as assessed by percentage of clot lysis determined 30 minutes after the maximum amplitude is reached (LY30) between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo.\n\n Specific aim 2: To explore the underlying mechanism of TXA by comparing fibrinolytic pathway mediator activity between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo.\n\n Secondary hypothesis: The null hypothesis is that there will be no change in fibrinolytic pathway mediators between subjects who are randomly assigned to TXA and subjects who are randomly assigned to placebo.\n\n Specific aim 3: To estimate the association between the degree of fibrinolysis based on kaolin activated TEG results and fibrinolytic pathway mediators on primary and secondary clinical outcomes.\n\n Tertiary hypothesis: The null hypothesis is that no association will exist between the degree of fibrinolysis and fibrinolytic pathway mediators and primary and secondary clinical outcomes.\n3. Study Enrollment\n\n EMS agencies will carry blinded sealed study drug kits. Once the seal is broken in the presence of the patient, the patient is randomized. The EMS study drug kit will contain a vial of either 1 gram TXA, 2 grams TXA, or placebo. EMS will mix the study drug in a 250 mL bag of 0.9% sodium chloride and administer the bolus infusion as soon as life-saving interventions are performed. After randomization, EMS will provide the study drug kit ID# to the receiving pharmacy. The hospital pharmacist will obtain the randomization assignment from the coordinating center and prepare the appropriate drug to be administered in the hospital.\n4. Sample Size and Statistical Analysis\n\n The total sample size is 963 (321 per group) starting treatment, which will allow for 80% power to detect a 7.1% absolute difference in favorable long-term neurological outcome as determined by the GOS-E 6 months after injury comparing the combined TXA treatment groups to placebo, using a one-sided, level 0.1 test.\n\n Statistical analysis of primary hypothesis: Modified intention-to-treat analysis using logistic regression to test for association and estimate the strength of the association of treatment group with a favorable 6-month outcome (defined as a GOS-E \\> 4), after adjustment for study site.\n5. Human subjects protection\n\nThis study qualifies for the exception from informed consent (EFIC) required for emergency research outlined in FDA regulation 21CFR50.24. EFIC applies because of life-threatening situation, intervention must be administered before consent is feasible, no reasonable way to identify prospectively individuals at risk, patients have the prospect of benefit from the treatment, and the research could not practically be carried out without the waiver of consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Blunt or penetrating traumatic mechanism consistent with traumatic brain injury\n2. Prehospital Glasgow Coma Score (GCS) score ≤ 12 at any time prior to randomization and administration of sedative and/or paralytic agents\n3. Prehospital systolic blood pressure (SBP) ≥ 90 mmHg prior to randomization\n4. Prehospital intravenous (IV) or intraosseous (IO) access\n5. Estimated Age ≥ 15 (or estimated weight \\> 50 kg if age is unknown)\n6. Emergency Medicine System (EMS) transport to a participating trauma center\n\nExclusion Criteria:\n\n1. Prehospital GCS=3 with no reactive pupil\n2. Estimated time from injury to hospital arrival \\> 2 hours\n3. Unknown time of injury - no known reference times to support estimation\n4. Clinical suspicion by EMS of seizure activity or known history of seizures, acute myocardial infarction (MI) or stroke\n5. Cardio-pulmonary resuscitation (CPR) by EMS prior to randomization\n6. Burns \\> 20% total body surface area (TBSA)\n7. Suspected or known prisoners\n8. Suspected or known pregnancy\n9. Prehospital TXA given prior to randomization\n10. Subjects who have activated the "opt-out" process when required by the local regulatory board'}, 'identificationModule': {'nctId': 'NCT01990768', 'acronym': 'TXA', 'briefTitle': 'Prehospital Tranexamic Acid Use for Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Prehospital Tranexamic Acid Use for Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '47114'}, 'secondaryIdInfos': [{'id': '5U01HL077863-09', 'link': 'https://reporter.nih.gov/quickSearch/5U01HL077863-09', 'type': 'NIH'}, {'id': 'TATRC Log No. 13335004-A', 'type': 'OTHER_GRANT', 'domain': 'US Army Medical Research Acquisition Activity (USAMRAA)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 gram Tranexamic Acid (TXA)', 'description': 'Loading dose of 1 gram TXA given prior to hospital arrival followed by a 1 gram TXA infusion over 8 hours after hospital arrival', 'interventionNames': ['Drug: 1 gram Tranexamic Acid (TXA)']}, {'type': 'EXPERIMENTAL', 'label': '2 grams TXA', 'description': 'Loading dose of 2 gram TXA given prior to hospital arrival followed by a placebo of 0.9% Sodium Chloride solution infusion over 8 hours after hospital arrival', 'interventionNames': ['Drug: 2 grams TXA']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9% Sodium Chloride injectable', 'description': 'Loading dose of 0.9% Sodium Chloride solution given prior to hospital arrival followed by a placebo of 0.9% Sodium Chloride solution infusion over 8 hours after hospital arrival', 'interventionNames': ['Drug: 0.9% Sodium Chloride injectable']}], 'interventions': [{'name': '1 gram Tranexamic Acid (TXA)', 'type': 'DRUG', 'otherNames': ['Cyklokapron'], 'description': 'TXA produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin.', 'armGroupLabels': ['1 gram Tranexamic Acid (TXA)']}, {'name': '2 grams TXA', 'type': 'DRUG', 'otherNames': ['Cyklokapron'], 'description': 'TXA produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin.', 'armGroupLabels': ['2 grams TXA']}, {'name': '0.9% Sodium Chloride injectable', 'type': 'DRUG', 'otherNames': ['Normal saline solution'], 'description': 'Loading dose of 0.9% Sodium Chloride solution given prior to hospital arrival followed by a placebo of 0.9% Sodium Chloride solution infusion over 8 hours after hospital arrival. No active drug is added to the solution.', 'armGroupLabels': ['0.9% Sodium Chloride injectable']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Resuscitation Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St Paul Regions Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Center for Resuscitation Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital - Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Milwaukee Resuscitation Research Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'V5Z 1 M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Regional Coordinating Center', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto RescuNet', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Susanne May, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Martin Schreiber, MD FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Public use data set will be shared with NHLBI. It will include individual patient data that are de-identified. It will be available 3 years after study completion. This is currently expected for the end of 2020. The data should then be available at \\<https://biolincc.nhlbi.nih.gov/studies/\\>.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}, {'name': 'American Heart Association', 'class': 'OTHER'}, {'name': 'Defence Research and Development Canada', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Susanne May', 'investigatorAffiliation': 'University of Washington'}}}}