Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-31 @ 6:05 PM
Study NCT ID:
NCT01227005
Status:
COMPLETED
Last Update Posted:
2018-06-04
First Post:
2010-10-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001803', 'term': 'Blood Transfusion'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bryan.a.cotton@uth.tmc.edu', 'phone': '713-500-7354', 'title': 'Bryan A. Cotton, MD, MPH', 'organization': 'University of Texas Health Science Center-Houston'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'First, we failed to specifically exclude patients with severe TBI from our initial protocol. Finally, we did not use an objective scoring system to randomize patients and, therefore, did not always include patients who would have received an MT.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Whole Blood', 'description': 'Whole Blood plus pooled platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).', 'otherNumAtRisk': 55, 'otherNumAffected': 1, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Component Therapy', 'description': 'Red blood cells, plasma, platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic reaction to blood product', 'notes': 'Allergic reaction to blood product in WB arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Units of Blood Products Required During the First 24 Hours After Emergency Department Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Blood', 'description': 'Whole Blood plus pooled platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}, {'id': 'OG001', 'title': 'Component Therapy', 'description': 'Red blood cells, plasma, platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '24'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'first 24 hours after ED admission', 'description': 'Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)', 'unitOfMeasure': 'units of blood', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24-hour Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Blood', 'description': 'Whole Blood plus pooled platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}, {'id': 'OG001', 'title': 'Component Therapy', 'description': 'Red blood cells, plasma, platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 24 hours after ED admission', 'description': 'Mortality rate at 24 hours after arrival', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Blood', 'description': 'Whole Blood plus pooled platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}, {'id': 'OG001', 'title': 'Component Therapy', 'description': 'Red blood cells, plasma, platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'first 30 days after ED admission', 'description': 'Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Whole Blood', 'description': 'Whole Blood plus pooled platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}, {'id': 'FG001', 'title': 'Component Therapy', 'description': 'Red blood cells, plasma, platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Whole Blood', 'description': 'Whole Blood plus pooled platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}, {'id': 'BG001', 'title': 'Component Therapy', 'description': 'Red blood cells, plasma, platelets\n\nTransfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '56'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '56'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2010-10-20', 'resultsFirstSubmitDate': '2014-05-19', 'studyFirstSubmitQcDate': '2010-10-21', 'lastUpdatePostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-26', 'studyFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Units of Blood Products Required During the First 24 Hours After Emergency Department Admission', 'timeFrame': 'first 24 hours after ED admission', 'description': 'Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)'}], 'secondaryOutcomes': [{'measure': '24-hour Mortality', 'timeFrame': 'First 24 hours after ED admission', 'description': 'Mortality rate at 24 hours after arrival'}, {'measure': '30-day Mortality', 'timeFrame': 'first 30 days after ED admission', 'description': 'Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transfusion', 'Whole Blood', 'Trauma', 'Coagulopathy', 'Component Therapy', 'Civilian', 'Military'], 'conditions': ['Trauma/Injury Problem']}, 'referencesModule': {'references': [{'pmid': '8676771', 'type': 'BACKGROUND', 'citation': 'Erber WN, Tan J, Grey D, Lown JA. Use of unrefrigerated fresh whole blood in massive transfusion. Med J Aust. 1996 Jul 1;165(1):11-3. doi: 10.5694/j.1326-5377.1996.tb124809.x.'}, {'pmid': '3172799', 'type': 'BACKGROUND', 'citation': 'Mohr R, Martinowitz U, Lavee J, Amroch D, Ramot B, Goor DA. The hemostatic effect of transfusing fresh whole blood versus platelet concentrates after cardiac operations. J Thorac Cardiovasc Surg. 1988 Oct;96(4):530-4.'}, {'pmid': '5333702', 'type': 'BACKGROUND', 'citation': 'Oberman HA. The indications for transfusion of freshly drawn blood. JAMA. 1967 Jan 9;199(2):93-7. No abstract available.'}, {'pmid': '10912871', 'type': 'BACKGROUND', 'citation': 'Grosso SM, Keenan JO. Whole blood transfusion for exsanguinating coagulopathy in a US field surgical hospital in postwar Kosovo. J Trauma. 2000 Jul;49(1):145-8. doi: 10.1097/00005373-200007000-00022.'}, {'pmid': '12768106', 'type': 'BACKGROUND', 'citation': 'Ledgerwood AM, Lucas CE. A review of studies on the effects of hemorrhagic shock and resuscitation on the coagulation profile. J Trauma. 2003 May;54(5 Suppl):S68-74. doi: 10.1097/01.TA.0000064513.59253.70.'}, {'pmid': '23979267', 'type': 'DERIVED', 'citation': 'Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0.'}]}, 'descriptionModule': {'briefSummary': 'The proposal will assess if patients who require massive transfusion can be accurately predicted early after emergency department arrival and assess if the use of stored whole blood during initial resuscitation will reduce transfusion needs compared to transfusion with component therapy and thus improve outcome.', 'detailedDescription': "Background: The acquired coagulopathy of trauma is responsible for a large percentage of early deaths in civilian trauma practice and is a major cause of battlefield mortality. Widespread recognition has provided a rationale for fundamental changes in the initial management of severely injured patients through prevention of hypothermia, damage control surgery, massive transfusion protocols and early triage to intensive care units for optimized resuscitation. Despite these major advances, hemorrhage remains a leading cause of early death in both civilian trauma and military combat casualty care. However, it is unclear how early whole blood will affect coagulopathy in this cohort of patients as compared to the current standard of care. Objective/Hypothesis: The proposal will assess if patients who require massive transfusion can be accurately predicted early after emergency department arrival and assess if the use of stored whole blood during initial resuscitation will reduce transfusion needs compared to transfusion with component therapy and thus improve outcome.\n\nStudy Design: As a first step in testing this hypothesis, we will test commonly utilized point of care analysis devices and determine their reliability in predicting transfusion requirements in severely injured trauma patients within 20 minutes after arrival in the emergency department. Furthermore, we will prospectively randomize severely injured patients who require a blood transfusion to receive either stored whole blood and pooled platelets or component therapy (packed red blood cells, fresh frozen plasma, and platelets, our current standard of care) and compare the ability of stored whole blood to reduce transfusion needs and improve clinical outcomes.\n\nRelevance: Severe uncontrollable coagulopathy in major trauma patients continues to be a major determinant of trauma mortalities. The proposed effort aims to provide an early, coagulopathy-based prediction model to identify patients at risk for massive transfusion. Moreover, our proposal intends to evaluate early stored whole blood transfusion in this at risk patient population and determine stored whole blood's ability to prevent or control severe coagulopathy compared to standard transfusion care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Meet Code 3 status; Code 3 is determined by the following criteria (Patients must meet at least one of the following physiologic and/or anatomic criteria):\n\n * Physiologic criteria indicating high risk or life threatening injuries\n * GCS \\<10 (Glasgow Coma Scale)\n * SBP \\<90 (Systolic blood pressure)\n * RR \\<10 or \\>29 (Respiratory rate)\n * HR \\>120 (Heart rate)\n * intubated\n * Base Deficit \\> 6\n * Anatomic criteria indicating high risk or life threatening injuries\n * Any penetrating injury to torso, groin, or neck\n * Amputation proximal to the ankle or wrist\n * Uncontrolled external hemorrhage\n * Two or more long bone fractures\n * Pelvic fracture\n * Paraplegia or quadriplegia\n * Combination trauma with burns ≥ 20% BSA (body surface area)\n3. Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.\n\nExclusion Criteria:\n\n1. Death thought to be imminent, suggesting a futile resuscitation effort\n2. Known or assumed religious objection to blood products\n3. Do not resuscitate order in place\n4. Women who present to the ED who are obviously pregnant.\n5. Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.'}, 'identificationModule': {'nctId': 'NCT01227005', 'briefTitle': 'Early Whole Blood in Patients Requiring Transfusion After Major Trauma', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Early Whole Blood in Patients Requiring Transfusion After Major Trauma', 'orgStudyIdInfo': {'id': 'W81XWH-07-1-0229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Whole Blood', 'description': 'Whole Blood plus pooled platelets', 'interventionNames': ['Biological: Transfusion of blood products']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Component Therapy', 'description': 'Red blood cells, plasma, platelets', 'interventionNames': ['Biological: Transfusion of blood products']}], 'interventions': [{'name': 'Transfusion of blood products', 'type': 'BIOLOGICAL', 'description': 'The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).', 'armGroupLabels': ['Component Therapy', 'Whole Blood']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital - Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Bryan Cotton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Surgery', 'investigatorFullName': 'Bryan Cotton', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}