Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-28 @ 9:03 AM
Study NCT ID:
NCT01038557
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2009-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Frozen Red Blood Cell Transfusions in Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schreibm@ohsu.edu', 'phone': '503-494-8324', 'title': 'Dr. Martin A. Schreiber', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse event data was collected during the patient's hospital admission, up to 6 months.", 'eventGroups': [{'id': 'EG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 24, 'seriousNumAtRisk': 82, 'deathsNumAffected': 3, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 86, 'otherNumAffected': 22, 'seriousNumAtRisk': 86, 'deathsNumAffected': 3, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 24, 'seriousNumAtRisk': 86, 'deathsNumAffected': 3, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Infection', 'notes': 'All infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'notes': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pulmonary Embolism', 'notes': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'notes': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tissue Oxygenation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '98.2', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '98.3', 'spread': '14.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Percentage of baseline (3 hours post transfusion compared to baseline)', 'description': 'Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean percent change in tissue oxygenation (StO2) over time is reported for subjects with continuous data. Data on subjects whose NIRS device fell off or there was discontinuity in recording were excluded.'}, {'type': 'SECONDARY', 'title': '2,3 DPG Levels After Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.47'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '0.47'}, {'value': '0.31', 'groupId': 'OG002', 'lowerLimit': '0.23', 'upperLimit': '0.56'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 hours post transfusion', 'description': '2,3 DPG levels 12 hours after transfusion', 'unitOfMeasure': 'g/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples to measure 2,3 DPG levels could not be collected from all subjects 12 hours after transfusion or results were not measurable.'}, {'type': 'SECONDARY', 'title': 'Free Hemoglobin Levels After Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '422'}, {'value': '194', 'groupId': 'OG001', 'lowerLimit': '106', 'upperLimit': '194'}, {'value': '174', 'groupId': 'OG002', 'lowerLimit': '82', 'upperLimit': '287'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 hours after transfusion', 'description': 'Free hemoglobin levels 12 hours after transfusion', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples to measure free hemoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.'}, {'type': 'SECONDARY', 'title': 'Haptoglobin Levels 12 Hours After Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '897', 'groupId': 'OG000', 'lowerLimit': '349', 'upperLimit': '1775'}, {'value': '1470', 'groupId': 'OG001', 'lowerLimit': '494', 'upperLimit': '2360'}, {'value': '1350', 'groupId': 'OG002', 'lowerLimit': '411', 'upperLimit': '2700'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 hours after transfusion', 'description': 'Haptoglobin levels after transfusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood samples to measure haptoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.'}, {'type': 'SECONDARY', 'title': 'Clinical Outcomes - Hospital Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '20.5'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Clinical outcomes - Number of days admitted to the hospital within a 6 month window.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Outcomes - ICU Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '14.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Number of days admitted to the ICU during hospital admission', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Outcomes - Ventilator Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4.25'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Renal Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Number of participants who developed acute renal failure while hospitalized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Outcomes - Acute Respiratory Distress Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Number of subjects who developed acute respiratory distress syndrome while hospitalized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Outcomes - Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'OG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Number of subjects who developed infections while hospitalized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'FG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'FG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Refrigerated RBCs 0-14 Days Old', 'description': 'Standard, refrigerated RBC units stored up to 14 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'BG001', 'title': 'Refrigerated RBCs 15-42 Days Old', 'description': 'Standard, refrigerated RBC units stored 15-42 days\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'BG002', 'title': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.\n\nRBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52.3', 'groupId': 'BG000', 'lowerLimit': '29.4', 'upperLimit': '62.5'}, {'value': '47.9', 'groupId': 'BG001', 'lowerLimit': '28.1', 'upperLimit': '67.0'}, {'value': '49.3', 'groupId': 'BG002', 'lowerLimit': '30.9', 'upperLimit': '62.6'}, {'value': '49.3', 'groupId': 'BG003', 'lowerLimit': '29.4', 'upperLimit': '62.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Injury Severity Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '32'}, {'value': '19', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '26'}, {'value': '19', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '26'}, {'value': '19', 'groupId': 'BG003', 'lowerLimit': '10', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale (1 best to 75 worst)', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2009-12-23', 'resultsFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-16', 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue Oxygenation', 'timeFrame': 'Percentage of baseline (3 hours post transfusion compared to baseline)', 'description': 'Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.'}], 'secondaryOutcomes': [{'measure': '2,3 DPG Levels After Transfusion', 'timeFrame': '12 hours post transfusion', 'description': '2,3 DPG levels 12 hours after transfusion'}, {'measure': 'Free Hemoglobin Levels After Transfusion', 'timeFrame': '12 hours after transfusion', 'description': 'Free hemoglobin levels 12 hours after transfusion'}, {'measure': 'Haptoglobin Levels 12 Hours After Transfusion', 'timeFrame': '12 hours after transfusion', 'description': 'Haptoglobin levels after transfusion'}, {'measure': 'Clinical Outcomes - Hospital Days', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Clinical outcomes - Number of days admitted to the hospital within a 6 month window.'}, {'measure': 'Clinical Outcomes - ICU Days', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Number of days admitted to the ICU during hospital admission'}, {'measure': 'Clinical Outcomes - Ventilator Days', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months'}, {'measure': 'Number of Participants With Acute Renal Failure', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Number of participants who developed acute renal failure while hospitalized.'}, {'measure': 'Clinical Outcomes - Acute Respiratory Distress Syndrome', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Number of subjects who developed acute respiratory distress syndrome while hospitalized.'}, {'measure': 'Clinical Outcomes - Infections', 'timeFrame': 'from time of randomization through hospital discharged, assessed up to 6 months', 'description': 'Number of subjects who developed infections while hospitalized.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['frozen', 'red blood cells', 'transfusion', 'trauma'], 'conditions': ['Blood Loss', 'Anemia', 'Trauma']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to look at red blood cell (RBC) transfusions in trauma patients and evaluate for any differences between the age of the RBCs and how they were stored. The investigators will specifically look for the following differences between study groups:\n\n1. the transfused red blood cells' ability to delivery oxygen to the tissues\n2. differences in biochemical markers in subjects and units transfused, and\n3. how the subject's internal organs are working and if they develop any infections"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trauma Service with an Injury Severity Score \\> 4\n* Require a blood (PRBC) transfusion\n* Transfusion is not emergent\n* Able to obtain consent from patient or appropriate 3rd party prior to 1st transfusion\n\nExclusion Criteria:\n\n* Inability to adhere to blood age randomization due to limitations of the blood bank inventory\n* Bilateral hand injuries that prevent StO2 measurements\n* Age \\< 15\n* Pregnancy\n* Massive transfusion (=/\\> 10 units in 24 hours) in last 3 months\n* Hemodynamically unstable or need for transfusion in \\< 3 hours'}, 'identificationModule': {'nctId': 'NCT01038557', 'briefTitle': 'Frozen Red Blood Cell Transfusions in Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients', 'orgStudyIdInfo': {'id': '002-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Refrigerated RBCs 0-14 days old', 'description': 'Standard, refrigerated RBC units stored up to 14 days', 'interventionNames': ['Biological: RBC units']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Refrigerated RBCs 15-42 days old', 'description': 'Standard, refrigerated RBC units stored 15-42 days', 'interventionNames': ['Biological: RBC units']}, {'type': 'EXPERIMENTAL', 'label': 'Frozen RBCs', 'description': 'RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.', 'interventionNames': ['Biological: RBC units']}], 'interventions': [{'name': 'RBC units', 'type': 'BIOLOGICAL', 'description': 'When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.', 'armGroupLabels': ['Frozen RBCs', 'Refrigerated RBCs 0-14 days old', 'Refrigerated RBCs 15-42 days old']}]}, 'contactsLocationsModule': {'locations': [{'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 & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Martin Schreiber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Air Force', 'class': 'FED'}, {'name': 'Armed Services Blood Program', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Chief of Trauma', 'investigatorFullName': 'Martin A Schreiber, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}