Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-02 @ 4:57 AM
Study NCT ID:
NCT04704869
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C026912', 'term': 'cryoprecipitate coagulum'}, {'id': 'D004906', 'term': 'Erythrocyte Count'}, {'id': 'D010976', 'term': 'Platelet Count'}], 'ancestors': [{'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D010979', 'term': 'Platelet Function Tests'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bryan.A.Cotton@uth.tmc.edu', 'phone': '713-500-7313', 'title': 'Bryan A Cotton, MD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': '28-day vital status was not available from any source for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm; therefore, all-Cause Mortality data could not be assessed for 34 in the Massive Transfusion arm and 39 in the Early Cryoprecipitate + Massive Transfusion arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.', 'otherNumAtRisk': 805, 'deathsNumAtRisk': 771, 'otherNumAffected': 0, 'seriousNumAtRisk': 805, 'deathsNumAffected': 201, 'seriousNumAffected': 83}, {'id': 'EG001', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.', 'otherNumAtRisk': 799, 'deathsNumAtRisk': 760, 'otherNumAffected': 0, 'seriousNumAtRisk': 799, 'deathsNumAffected': 192, 'seriousNumAffected': 84}], 'seriousEvents': [{'term': 'Venous thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 805, 'numEvents': 59, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 799, 'numEvents': 58, 'numAffected': 55}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial thrombotic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 805, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 799, 'numEvents': 27, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Serious transfusion related adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 805, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 799, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Mortality From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '771', 'groupId': 'OG000'}, {'value': '760', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.17', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days after emergency department (ED) admission', 'description': 'Mortality from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Vital status was not available from any source for 34 in the Massive Transfusion Protocol arm and 39 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. Data presented are from an intention to treat analysis.'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality at 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '784', 'groupId': 'OG000'}, {'value': '795', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 hours after ED admission', 'description': 'Mortality from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '783', 'groupId': 'OG000'}, {'value': '794', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after ED admission', 'description': 'Mortality from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '799', 'groupId': 'OG000'}, {'value': '805', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '29.4'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '24.3', 'upperLimit': '30.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after ED admission', 'description': 'Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '799', 'groupId': 'OG000'}, {'value': '805', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '30.0'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '24.6', 'upperLimit': '31.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after ED admission', 'description': 'Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death From Bleeding at 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '784', 'groupId': 'OG000'}, {'value': '795', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 hours after ED admission', 'description': 'Death related to exsanguination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Death From Bleeding at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '783', 'groupId': 'OG000'}, {'value': '794', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after ED admission', 'description': 'Death related to exsanguination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '9'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours', 'description': 'Number of units of RBCs', 'unitOfMeasure': 'Units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Transfusion Requirements (Number of Units of Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours', 'description': 'Number of units of plasma', 'unitOfMeasure': 'units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Transfusion Requirements (Number of Units of Platelets)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours', 'description': 'Number of units of platelets', 'unitOfMeasure': 'Units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Transfusion Requirements (Number of Units of Cryoprecipitate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours', 'description': 'Number of units of cryoprecipitate', 'unitOfMeasure': 'Units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Destination of Participant at Time of Discharge From Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'title': 'Home', 'measurements': [{'value': '280', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}, {'title': 'Nursing home/rehabilitation facility', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Other hospital', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the time of discharge from hospital, about 11-27 days after admission', 'description': 'Destination of participant at time of discharge from hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 431 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 424 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '0.72'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.73'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 458 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 475 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by the Glasgow Outcome Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'title': 'Low disability', 'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}, {'title': 'Moderate disability', 'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}, {'title': 'Severe disability', 'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}, {'title': 'Persistent vegetative state', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Death', 'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome:\n\n1. Death - Severe injury or death without recovery of consciousness\n2. Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions\n3. Severe disability - Severe injury with permanent need for help with daily living\n4. Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment\n5. Low disability - Light damage with minor neurological and psychological deficits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 93 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 94 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.93'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '0.78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months after ED admission', 'description': 'The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 350 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 331 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by the Glasgow Outcome Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'timeFrame': '6 months after ED admission', 'description': 'The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome:\n\n1. Death - Severe injury or death without recovery of consciousness\n2. Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions\n3. Severe disability - Severe injury with permanent need for help with daily living\n4. Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment\n5. Low disability - Light damage with minor neurological and psychological deficits', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected because the survey was not included on the 6-month follow-up. As a result, no participants received the survey, and therefore, no participants were analyzed in either study arm.'}, {'type': 'SECONDARY', 'title': 'Hospital Resource Use as Assessed by Number of Ventilator Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '763', 'groupId': 'OG000'}, {'value': '771', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'Number of ventilator days during hospitalization', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '763', 'groupId': 'OG000'}, {'value': '771', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'Number of ICU days during hospitalization', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}, {'type': 'SECONDARY', 'title': 'Hospital Resource Use as Assessed by Number of Hospital Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '763', 'groupId': 'OG000'}, {'value': '772', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'OG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '27'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'Total number of hospital days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected from 33 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'FG001', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '805'}, {'groupId': 'FG001', 'numSubjects': '799'}]}, {'type': 'Completed 28-day Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '771'}, {'groupId': 'FG001', 'numSubjects': '760'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '771'}, {'groupId': 'FG001', 'numSubjects': '760'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '39'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '799', 'groupId': 'BG000'}, {'value': '805', 'groupId': 'BG001'}, {'value': '1604', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nCryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'BG001', 'title': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.\n\nRed Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nPlatelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.\n\nWhole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '785', 'groupId': 'BG000'}, {'value': '796', 'groupId': 'BG001'}, {'value': '1581', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '55'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '55'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '55'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Age data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '785', 'groupId': 'BG000'}, {'value': '796', 'groupId': 'BG001'}, {'value': '1581', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '618', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1251', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity data were only collected from 48 US participants.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Black', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race data were only collected from 48 US participants.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '799', 'groupId': 'BG000'}, {'value': '805', 'groupId': 'BG001'}, {'value': '1604', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '799', 'groupId': 'BG000'}, {'value': '805', 'groupId': 'BG001'}, {'value': '1604', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '775', 'groupId': 'BG000'}, {'value': '780', 'groupId': 'BG001'}, {'value': '1555', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time from injury to ED arrival', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '799', 'groupId': 'BG000'}, {'value': '805', 'groupId': 'BG001'}, {'value': '1604', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '99'}, {'value': '77', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '100'}, {'value': '76', 'groupId': 'BG002', 'lowerLimit': '55', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of Participants who arrived at the Emergency Department with a blunt injury', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '785', 'groupId': 'BG000'}, {'value': '796', 'groupId': 'BG001'}, {'value': '1581', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '495', 'groupId': 'BG000'}, {'value': '519', 'groupId': 'BG001'}, {'value': '1014', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number of participants who arrived in the Emergency Department with a blunt injury data were not be collected for 9 in the Massive Transfusion Protocol arm and for 14 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.'}, {'title': 'Number of Participants who arrived to the Emergency Department in cardiac arrest', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'BG000'}, {'value': '735', 'groupId': 'BG001'}, {'value': '1452', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number of participants who arrived to the Emergency Department in cardiac arrest were not be collected for 70 in the Massive Transfusion Protocol arm and for 82 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-30', 'size': 1425644, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-30T18:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1604}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2021-01-06', 'resultsFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2021-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-23', 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Mortality From Any Cause', 'timeFrame': '28 days after emergency department (ED) admission', 'description': 'Mortality from any cause'}], 'secondaryOutcomes': [{'measure': 'All Cause Mortality at 6 Hours', 'timeFrame': '6 hours after ED admission', 'description': 'Mortality from any cause'}, {'measure': 'All Cause Mortality at 24 Hours', 'timeFrame': '24 hours after ED admission', 'description': 'Mortality from any cause'}, {'measure': 'All Cause Mortality at 6 Months', 'timeFrame': '6 months after ED admission', 'description': 'Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.'}, {'measure': 'All Cause Mortality at 12 Months', 'timeFrame': '12 months after ED admission', 'description': 'Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated.'}, {'measure': 'Death From Bleeding at 6 Hours', 'timeFrame': '6 hours after ED admission', 'description': 'Death related to exsanguination'}, {'measure': 'Death From Bleeding at 24 Hours', 'timeFrame': '24 hours after ED admission', 'description': 'Death related to exsanguination'}, {'measure': 'Transfusion Requirements (Number of Units of Red Blood Cells (RBCs))', 'timeFrame': 'from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours', 'description': 'Number of units of RBCs'}, {'measure': 'Transfusion Requirements (Number of Units of Plasma)', 'timeFrame': 'from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours', 'description': 'Number of units of plasma'}, {'measure': 'Transfusion Requirements (Number of Units of Platelets)', 'timeFrame': 'from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours', 'description': 'Number of units of platelets'}, {'measure': 'Transfusion Requirements (Number of Units of Cryoprecipitate)', 'timeFrame': 'from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours', 'description': 'Number of units of cryoprecipitate'}, {'measure': 'Destination of Participant at Time of Discharge From Hospital', 'timeFrame': 'at the time of discharge from hospital, about 11-27 days after admission', 'description': 'Destination of participant at time of discharge from hospital'}, {'measure': 'Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.'}, {'measure': 'Quality of Life as Assessed by the Glasgow Outcome Score', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome:\n\n1. Death - Severe injury or death without recovery of consciousness\n2. Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions\n3. Severe disability - Severe injury with permanent need for help with daily living\n4. Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment\n5. Low disability - Light damage with minor neurological and psychological deficits'}, {'measure': 'Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)', 'timeFrame': '6 months after ED admission', 'description': 'The 5-level EQ-5D version (EQ-5D-5L) score range was -0.148 (worst health state) to 0.949 (best health state). A higher score indicating a better health state.'}, {'measure': 'Quality of Life as Assessed by the Glasgow Outcome Score', 'timeFrame': '6 months after ED admission', 'description': 'The Glasgow Outcome Score ranges from 1 to 5, with a higher score indicating a better outcome:\n\n1. Death - Severe injury or death without recovery of consciousness\n2. Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions\n3. Severe disability - Severe injury with permanent need for help with daily living\n4. Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment\n5. Low disability - Light damage with minor neurological and psychological deficits'}, {'measure': 'Hospital Resource Use as Assessed by Number of Ventilator Days', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'Number of ventilator days during hospitalization'}, {'measure': 'Hospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) Days', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'Number of ICU days during hospitalization'}, {'measure': 'Hospital Resource Use as Assessed by Number of Hospital Days', 'timeFrame': 'Day of hospital discharge or 28 days after ED admission (whichever comes first)', 'description': 'Total number of hospital days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma Injury']}, 'referencesModule': {'references': [{'pmid': '37824155', 'type': 'RESULT', 'citation': 'Davenport R, Curry N, Fox EE, Thomas H, Lucas J, Evans A, Shanmugaranjan S, Sharma R, Deary A, Edwards A, Green L, Wade CE, Benger JR, Cotton BA, Stanworth SJ, Brohi K; CRYOSTAT-2 Principal Investigators. Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1882-1891. doi: 10.1001/jama.2023.21019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to compare standard of care (SOC) massive transfusion protocol to SOC massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of emergency department arrival).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is judged to be an adult (according to local practice, e.g. 16 years or older in UK) and has sustained severe traumatic injury. In the event the age is unknown, estimated body weight ≥50 kg.\n* The patient is deemed by the attending clinician to have on-going active hemorrhage AND REQUIRES Activation of the local major hemorrhage protocol for management of severe blood loss AND HAS STARTED or HAS RECEIVED at least one unit of any blood component\n\nExclusion Criteria:\n\n* The patient has been transferred from another hospital\n* The trauma team leader deems the injuries incompatible with life\n* More than 3 hours have elapsed from the time of injury\n* Prisoner (as defined as someone admitted from a correctional facility)\n* Known "Do Not Resuscitate" orders\n* Enrolled in a concurrent ongoing interventional, randomized clinical trial\n* Patients who wear "opt out" bracelet for study\n* Obvious pregnancy\n* Severely burned'}, 'identificationModule': {'nctId': 'NCT04704869', 'briefTitle': 'Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Multi-center, Randomized, Controlled Trial Evaluating the Effects of Early High-Dose Cryoprecipitate in Adult Patients With Major Trauma Hemorrhage Requiring Major Hemorrhage Protocol (MHP) Activation', 'orgStudyIdInfo': {'id': 'HSC-MS-19-0272'}, 'secondaryIdInfos': [{'id': 'ISRCTN14998314', 'type': 'REGISTRY', 'domain': 'International Standard Randomised Controlled Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).', 'interventionNames': ['Biological: Cryoprecipitate', 'Biological: Red Blood Cells', 'Biological: Plasma', 'Biological: Platelets', 'Biological: Whole Blood']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'description': 'Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.', 'interventionNames': ['Biological: Red Blood Cells', 'Biological: Plasma', 'Biological: Platelets', 'Biological: Whole Blood']}], 'interventions': [{'name': 'Cryoprecipitate', 'type': 'BIOLOGICAL', 'description': 'Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).', 'armGroupLabels': ['Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)']}, {'name': 'Red Blood Cells', 'type': 'BIOLOGICAL', 'otherNames': ['RBCs'], 'description': 'RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.', 'armGroupLabels': ['Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)']}, {'name': 'Plasma', 'type': 'BIOLOGICAL', 'description': 'Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.', 'armGroupLabels': ['Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)']}, {'name': 'Platelets', 'type': 'BIOLOGICAL', 'description': 'Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.', 'armGroupLabels': ['Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)']}, {'name': 'Whole Blood', 'type': 'BIOLOGICAL', 'description': 'Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.', 'armGroupLabels': ['Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)', 'Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BN2N 5BE', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Southmead Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospital of Coventry and Warwickshire', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'University Hospital Aintree', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. George's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M6 8HD', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Salford Royal Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Queens Medical Centre', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OX3 9UD', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'PR2 9HT', 'city': 'Preston', 'country': 'United Kingdom', 'facility': 'Royal Preston Hospital', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Northern General Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'University Hospital of North Staffordshire', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Bryan A Cotton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bryan Cotton', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary University of London', 'class': 'OTHER'}, {'name': 'NHS Blood and Transplant', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Bryan Cotton', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}