Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT01545232
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2012-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pragmatic, Randomized Optimal Platelet and Plasma Ratios
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D012771', 'term': 'Shock, Hemorrhagic'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D000073617', 'term': 'Transfusion-Related Acute Lung Injury'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D065227', 'term': 'Transfusion Reaction'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'John.Holcomb@uth.tmc.edu', 'phone': '713-500-5493', 'title': 'John Holcomb, M.D.', 'organization': 'University of Texas Health Science Center - Houston'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 30 days following ED admission', 'eventGroups': [{'id': 'EG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.', 'otherNumAtRisk': 338, 'otherNumAffected': 297, 'seriousNumAtRisk': 338, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.', 'otherNumAtRisk': 342, 'otherNumAffected': 310, 'seriousNumAtRisk': 342, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 265, 'numAffected': 231}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 239, 'numAffected': 216}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 110, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 102, 'numAffected': 91}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'Includes urinary tract infection, wound infection, line infection and other. Data is not available for the specific types of infection (i.e. urinary, wound, line).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 155, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 146, 'numAffected': 106}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 87, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 93, 'numAffected': 85}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventilator-associated pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 70, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 65, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfusion-related metabolic complications', 'notes': 'Hypocalcemia and hyperkalemia only', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 53, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 60, 'numAffected': 59}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Lung Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 56, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 66, 'numAffected': 57}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 55, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 57, 'numAffected': 48}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Complication', 'notes': 'Also includes complications related to injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 30, 'numAffected': 27}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Symptomatic pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Additional bleeding after hemostasis requiring intervention', 'notes': 'bleeding occurring after hemostasis requiring an interventional radiology or surgical procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asymptomatic pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed serological transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfusion-related allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile nonhemolytic transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Transfusion-associated circulatory overload', 'notes': 'Serious adverse event reportable to FDA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatremia associated with hypertonic saline use', 'notes': 'Serious adverse events reportable to FDA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 342, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '24-hour Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.08', 'groupDescription': "Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial's adaptive design. With 680 pts. \\& given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed.", 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The critical level for significance (p\\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.'}], 'paramType': 'NUMBER', 'timeFrame': 'First 24 hours after ED admission', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects who were randomized to each group'}, {'type': 'PRIMARY', 'title': '30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.12', 'groupDescription': "Initial sample size of 580 planned to detect clinically meaningful a 12% difference in 30-day mortality (23% vs. 35%),supported by prior data. DSMB increased sample size to 680 according to trial's adaptive design. With 680 patients \\& given final observed mortality proportions in the 1:1:1 group, PROPPR had 92% power to detect the pre-specified 12% difference at 30 days, if such differences existed.", 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The critical level for significance (p\\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.'}], 'paramType': 'NUMBER', 'timeFrame': 'First 30 days after ED admission', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects enrolled into each group.'}, {'type': 'PRIMARY', 'title': 'Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of ED admission, for up to 72 hours', 'description': 'Blood samples were collected at time of ED admission and over time to determine the incidence of reported venous thrombolic events (VTE).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects who were randomized to each group'}, {'type': 'SECONDARY', 'title': 'Hospital Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': "van Elteren's test for medians", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'first 30 days after ED admission', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of hospital free days for each group.'}, {'type': 'SECONDARY', 'title': 'Time to Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '179'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '181'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': "van Elteren's test for medians", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'ED admission to hospital discharge or 30 days, whichever comes first', 'description': 'Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to anatomic hemostasis'}, {'type': 'SECONDARY', 'title': 'Amount of Randomized Blood Products Given to Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '32'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours from randomization', 'unitOfMeasure': 'units of blood products', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Status at Time of Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': "van Elteren's test for medians", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge or 30 days, whichever comes first', 'description': 'The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.', 'unitOfMeasure': 'units on the GOSE scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Glasgow Outcome Extended Score (GOSE) Score on discharged patients who had a head injury (Abbreviated Injury Score (AIS) \\> 1) ranging from 1 to 8. The AIS is a coding scale to classify the injury severity. A score is created for each body region, type of anatomic structure (i.e. whole area, vessels,organs), and severity(minor to maximum).'}, {'type': 'SECONDARY', 'title': 'Incidence of Primary Surgical Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '8.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'ED admission to hospital discharge or 30 days, whichever comes first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Incidence of primary surgical procedure'}, {'type': 'SECONDARY', 'title': 'Incidence of Transfusion Related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'ED admission to hospital discharge or 30 days, whichever comes first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Incidence of transfusion related serious adverse events-Reportable to FDA'}, {'type': 'SECONDARY', 'title': 'Initial Hospital Discharge Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'title': 'Home', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Remained hospitalized at 30 days', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Morgue', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'generalized logit model regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Hospital discharge or 30 days, whichever comes first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Disposition of subject at time of hospital discharge'}, {'type': 'SECONDARY', 'title': 'Ventilator Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '14'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': "van Elteren's test for medians", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'first 30 days after ED admission', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of ventilator free days for each group.'}, {'type': 'SECONDARY', 'title': 'ICU Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': "van Elteren's test for medians", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'first 30 days after ED admission', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of ICU free days for each group.'}, {'type': 'SECONDARY', 'title': 'Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'OG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after ED admission', 'unitOfMeasure': 'units of blood products', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Unit of measure for outcome measures below is median number of blood product units that given in each group (1:1:1 or 1:1:2) from time initial hemostasis was complete (PROPPR randomized study products stopped) up to 24 hours following ED admission. Number of participants is based on those who survived up to 24 hours, not participants randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'FG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '338'}, {'groupId': 'FG001', 'numSubjects': '342'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '338'}, {'groupId': 'FG001', 'numSubjects': '342'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '680', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1:1:1 Blood Transfusion Ratio', 'description': '1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'BG001', 'title': '1:1:2 Blood Transfusion Ratio', 'description': '1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '338', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '680', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '15 years of age or older', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '283', 'groupId': 'BG001'}, {'value': '546', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '283', 'groupId': 'BG001'}, {'value': '560', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 680}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2012-02-29', 'resultsFirstSubmitDate': '2015-04-22', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-29', 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour Mortality', 'timeFrame': 'First 24 hours after ED admission'}, {'measure': '30-day Mortality', 'timeFrame': 'First 30 days after ED admission'}, {'measure': 'Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE)', 'timeFrame': 'From time of ED admission, for up to 72 hours', 'description': 'Blood samples were collected at time of ED admission and over time to determine the incidence of reported venous thrombolic events (VTE).'}], 'secondaryOutcomes': [{'measure': 'Hospital Free Days', 'timeFrame': 'first 30 days after ED admission'}, {'measure': 'Time to Hemostasis', 'timeFrame': 'ED admission to hospital discharge or 30 days, whichever comes first', 'description': 'Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.'}, {'measure': 'Amount of Randomized Blood Products Given to Hemostasis', 'timeFrame': '24 hours from randomization'}, {'measure': 'Functional Status at Time of Hospital Discharge', 'timeFrame': 'Hospital discharge or 30 days, whichever comes first', 'description': 'The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.'}, {'measure': 'Incidence of Primary Surgical Procedure', 'timeFrame': 'ED admission to hospital discharge or 30 days, whichever comes first'}, {'measure': 'Incidence of Transfusion Related Serious Adverse Events', 'timeFrame': 'ED admission to hospital discharge or 30 days, whichever comes first'}, {'measure': 'Initial Hospital Discharge Status', 'timeFrame': 'Hospital discharge or 30 days, whichever comes first'}, {'measure': 'Ventilator Free Days', 'timeFrame': 'first 30 days after ED admission'}, {'measure': 'ICU Free Days', 'timeFrame': 'first 30 days after ED admission'}, {'measure': 'Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission', 'timeFrame': '24 hours after ED admission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Massive Transfusion', 'Trauma', 'Coagulopathy', 'Trauma Induced Coagulopathy', 'Plasma', 'Platelets', 'Red Blood Cells', 'Mortality', 'Wounds and Injuries', 'Shock, Hemorrhagic', 'Shock', 'Pathologic Processes', 'Hemorrhage', 'Hemostatics', 'Coagulation', 'Transfusion-related acute lung injury (TRALI)', 'Inflammation'], 'conditions': ['Trauma']}, 'referencesModule': {'references': [{'pmid': '37058726', 'type': 'DERIVED', 'citation': 'Levy DT, Livingston CE, Saroukhani S, Fox EE, Wade CE, Holcomb JB, Gumbert SD, Galvagno SM Jr, Kaslow OY, Pittet JF, Pivalizza EG. Association of Opioid Administration During General Anesthesia and Survival for Severely Injured Trauma Patients: A Preplanned Secondary Analysis of the PROPPR Study. Anesth Analg. 2023 May 1;136(5):905-912. doi: 10.1213/ANE.0000000000006456. Epub 2023 Apr 14.'}, {'pmid': '33797501', 'type': 'DERIVED', 'citation': 'McCully BH, Wade CE, Fox EE, Inaba K, Cohen MJ, Holcomb JB, Schreiber MA; PROPPR study group. Temporal profile of the pro- and anti-inflammatory responses to severe hemorrhage in patients with venous thromboembolism: Findings from the PROPPR trial. J Trauma Acute Care Surg. 2021 May 1;90(5):845-852. doi: 10.1097/TA.0000000000003088.'}, {'pmid': '31050809', 'type': 'DERIVED', 'citation': 'DeSantis SM, Brown DW, Jones AR, Yamal JM, Pittet JF, Patel RP, Wade CE, Holcomb JB, Wang H; PROPPR Study Group. Characterizing red blood cell age exposure in massive transfusion therapy: the scalar age of blood index (SBI). Transfusion. 2019 Aug;59(8):2699-2708. doi: 10.1111/trf.15334. Epub 2019 May 3.'}, {'pmid': '30447946', 'type': 'DERIVED', 'citation': 'Jones AR, Patel RP, Marques MB, Donnelly JP, Griffin RL, Pittet JF, Kerby JD, Stephens SW, DeSantis SM, Hess JR, Wang HE; PROPPR Study Group. Older Blood Is Associated With Increased Mortality and Adverse Events in Massively Transfused Trauma Patients: Secondary Analysis of the PROPPR Trial. Ann Emerg Med. 2019 Jun;73(6):650-661. doi: 10.1016/j.annemergmed.2018.09.033. Epub 2018 Nov 15.'}, {'pmid': '30030268', 'type': 'DERIVED', 'citation': 'Cardenas JC, Zhang X, Fox EE, Cotton BA, Hess JR, Schreiber MA, Wade CE, Holcomb JB; PROPPR Study Group. Platelet transfusions improve hemostasis and survival in a substudy of the prospective, randomized PROPPR trial. Blood Adv. 2018 Jul 24;2(14):1696-1704. doi: 10.1182/bloodadvances.2018017699.'}, {'pmid': '29766088', 'type': 'DERIVED', 'citation': 'Henry B, Perez A, Trpcic S, Rizoli S, Nascimento B. Protecting study participants in emergency research: is community consultation before trial commencement enough? Trauma Surg Acute Care Open. 2017 Jul 12;2(1):e000084. doi: 10.1136/tsaco-2017-000084. eCollection 2017.'}, {'pmid': '28930959', 'type': 'DERIVED', 'citation': "Galvagno SM Jr, Fox EE, Appana SN, Baraniuk S, Bosarge PL, Bulger EM, Callcut RA, Cotton BA, Goodman M, Inaba K, O'Keeffe T, Schreiber MA, Wade CE, Scalea TM, Holcomb JB, Stein DM; PROPPR Study Group. Outcomes after concomitant traumatic brain injury and hemorrhagic shock: A secondary analysis from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios trial. J Trauma Acute Care Surg. 2017 Oct;83(4):668-674. doi: 10.1097/TA.0000000000001584. Epub 2017 Jun 6."}, {'pmid': '28731937', 'type': 'DERIVED', 'citation': 'Naumann DN, Vincent LE, Pearson N, Beaven A, Smith IM, Smith K, Toman E, Dorrance HR, Porter K, Wade CE, Cotton BA, Holcomb JB, Midwinter MJ. An adapted Clavien-Dindo scoring system in trauma as a clinically meaningful nonmortality endpoint. J Trauma Acute Care Surg. 2017 Aug;83(2):241-248. doi: 10.1097/TA.0000000000001517.'}, {'pmid': '25647203', 'type': 'DERIVED', 'citation': "Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12."}, {'pmid': '24996573', 'type': 'DERIVED', 'citation': "Baraniuk S, Tilley BC, del Junco DJ, Fox EE, van Belle G, Wade CE, Podbielski JM, Beeler AM, Hess JR, Bulger EM, Schreiber MA, Inaba K, Fabian TC, Kerby JD, Cohen MJ, Miller CN, Rizoli S, Scalea TM, O'Keeffe T, Brasel KJ, Cotton BA, Muskat P, Holcomb JB; PROPPR Study Group. Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: design, rationale and implementation. Injury. 2014 Sep;45(9):1287-95. doi: 10.1016/j.injury.2014.06.001. Epub 2014 Jun 10."}, {'pmid': '24335442', 'type': 'DERIVED', 'citation': 'Lissauer ME, Galvagno SM Jr, Rock P, Narayan M, Shah P, Spencer H, Hong C, Diaz JJ. Increased ICU resource needs for an academic emergency general surgery service*. Crit Care Med. 2014 Apr;42(4):910-7. doi: 10.1097/CCM.0000000000000099.'}]}, 'descriptionModule': {'briefSummary': "Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted to receive massive transfusion (\\[MT\\] (defined as receiving 10 units or more red blood cells (RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which clinicians make decisions about transfusion protocols for massively bleeding patients.\n\nPROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial at Level I Adult Trauma Centers in North America.", 'detailedDescription': 'Background: Multiple observational studies have reported that blood product component ratios (i.e., plasma:platelets:RBCs) that approach the 1:1:1 ratio, found in fresh whole blood, are associated with significant decreases in truncal hemorrhagic death and in overall 24-hour and 30-day mortality among injured patients. The rationale for the 1:1:1 ratio is that the closer a transfusion regimen approximates whole blood, the faster hemostasis will be achieved with minimum risk of coagulopathy. The current DoD guideline specifies the use of 1:1:1, and this practice is followed on almost all combat casualties. In other observational studies, leading centers have reported good outcomes across a range of different blood product ratios. For example, a 1:2 plasma:RBC ratio is used with little guidance regarding platelets. The proposed randomized trial is intended to resolve debate and uncertainty regarding optimum blood product ratios.\n\nStudy Design: Randomized, two-group, controlled Phase III trial with a Vanguard stage. Equal random allocation to treatment using stratified, permuted blocks with randomly chosen block sizes and stratification by site.\n\nObjective: To conduct a Phase III multi-site, randomized trial in subjects predicted to have a massive transfusion, comparing the efficacy and safety of 1:1:1 transfusion ratios of plasma and platelets to red blood cells (the closest approximation to reconstituted whole blood) with the 1:1:2 ratio. The co-primary outcomes will be 24-hour and 30-day mortality. The PROPPR Trial will be conducted with exception from informed consent (EFIC). Additionally, laboratory data from the trial will add to the understanding of trauma induced coagulopathy (TIC) and inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who require the highest trauma team activation at each participating center,\n* Estimated age of 15 years or older or greater than/equal to weight of 50 kg if age unknown,\n* Received directly from the injury scene,\n* Initiated transfusion of at least one unit of blood component within the first hour of arrival or during prehospital transport, and\n* Predicted to receive a MT by exceeding the threshold score of either the Assessment of Blood Consumption (ABC) score or the attending trauma physician\'s judgment criteria\n\nExclusion Criteria:\n\n* Received care (as defined as receiving a life saving intervention) from an outside hospital or healthcare facility (Procedures and care given at an outside health facility cannot be documented or controlled resulting in a high variability of standards of care and clinical outcomes.)\n* Moribund patient with devastating injuries and expected to die within one hour of Emergency Department (ED) admission\n* Prisoners, defined as those who have been directly admitted from a correctional facility\n* Patients requiring an emergency thoracotomy\n* Children under the age of 15 years or under 50 kg body weight if age unknown\n* Known pregnancy in the ED\n* Greater than 20% total body surface area (TBSA) burns\n* Suspected inhalation injury\n* Received greater than five consecutive minutes of cardiopulmonary resuscitation (CPR with chest compressions) in the pre-arrival or ED setting\n* Known Do Not Resuscitate (DNR) prior to randomization\n* Enrolled in a concurrent, ongoing interventional, randomized clinical trial\n* Patients who have activated the "opt-out" process or patients/legally authorized representatives that refuse blood products on arrival to ED.'}, 'identificationModule': {'nctId': 'NCT01545232', 'acronym': 'PROPPR', 'briefTitle': 'Pragmatic, Randomized Optimal Platelet and Plasma Ratios', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Pragmatic, Randomized Optimal Platelet and Plasma Ratios', 'orgStudyIdInfo': {'id': 'HSC-GEN-11-0174'}, 'secondaryIdInfos': [{'id': 'U01HL077863', 'link': 'https://reporter.nih.gov/quickSearch/U01HL077863', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1:1:1 Blood Transfusion Ratio', 'interventionNames': ['Biological: 1:1:1 Blood Transfusion Ratio']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1:1:2 Blood Transfusion Ratio', 'interventionNames': ['Biological: 1:1:2 Blood Transfusion Ratio']}], 'interventions': [{'name': '1:1:1 Blood Transfusion Ratio', 'type': 'BIOLOGICAL', 'description': 'Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.', 'armGroupLabels': ['1:1:1 Blood Transfusion Ratio']}, {'name': '1:1:2 Blood Transfusion Ratio', 'type': 'BIOLOGICAL', 'description': 'Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.', 'armGroupLabels': ['1:1:2 Blood Transfusion Ratio']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85721', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '45221', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center- Memorial Hermann Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington- Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'John Holcomb, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Resuscitation Outcomes Consortium', 'class': 'NETWORK'}, {'name': 'Defence Research and Development Canada', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'John Holcomb', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}