Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-08 @ 11:57 AM
Study NCT ID:
NCT02972593
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D001803', 'term': 'Blood Transfusion'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bmullis@iupui.edu', 'phone': '317-963-1966', 'title': 'Dr. Brian H. Mullis', 'organization': 'Indiana University School of Medicine Department of Orthopaedic Surgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Significant loss to follow up; Significant resistance by multiple providers at each site to allow conservative treatment algorithm (as most felt liberal was standard of care); Slow enrollment; No funding'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Liberal', 'description': 'Transfusion will be done to keep Hgb \\>7 g/dL.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Conservative', 'description': 'Transfusion will be done to keep Hgb \\> 5.5 g/dL.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Secondary DVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfusion-related acute lung injury (TRALI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liberal', 'description': 'Transfusion will be done to keep Hgb \\>7 g/dL.'}, {'id': 'OG001', 'title': 'Conservative', 'description': 'Transfusion will be done to keep Hgb \\> 5.5 g/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0122', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Data collapsed to participant level, creating an ever/never response for each participant for each infection outcome type. Analyses performed at the participant level to determine if proportion of outcome types were similar between transfusion groups using Fisher's Exact tests, due to small expected cell counts, using SAS v9.4 (SAS Institute, Cary, NC). Power analyses performed based on these proportions using bootstrapping methods in SAS and confirmed with nQuery v8.7.1.0."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'one year', 'description': 'Deep infection is defined as the need for intravenous antibiotics and/or a return to surgery for debridement. Superficial infection is defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Combined Secondary Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liberal', 'description': "Transfusion will be done to keep Hgb \\>7 g/dL.\n\nBlood and blood products for transfusion: Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb \\>7 g/dL."}, {'id': 'OG001', 'title': 'Conservative', 'description': 'Transfusion will be done to keep Hgb \\> 5.5 g/dL.\n\nIf the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.7742', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'one year', 'description': 'Combined (any) Secondary Outcomes: pulmonary embolism, deep venous thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Musculoskeletal Function Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liberal', 'description': 'Transfusion will be done to keep Hgb \\>7 g/dL.'}, {'id': 'OG001', 'title': 'Conservative', 'description': 'Transfusion will be done to keep Hgb \\> 5.5 g/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.1443', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': "The Musculoskeletal Function Assessment (MFA) evaluates the health status of patients with musculoskeletal disorders of the extremities, including patients with fractures and soft tissue injuries, repetitive motion disorders, osteoarthritis or rheumatoid arthritis. It describes patient functioning, assesses outcomes of surgical interventions and clinical trials, and monitors patients' functional status over time. The MFA is scored from 0 to 100 with 0 representing no dysfunction. Higher MFA scores/values represent a higher levels of dysfunction or worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sixty five patients completed 1 year follow up but 5 declined to complete the MFA, leaving sixty patients that completed 1 year MFA.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liberal', 'description': "Blood and blood products for transfusion. Transfusion will be done to keep Hgb \\>7 g/dL.\n\nBlood and blood products for transfusion: Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb \\>7 g/dL."}, {'id': 'FG001', 'title': 'Conservative', 'description': 'Blood and blood products for transfusion. Transfusion will be done to keep Hgb \\> 5.5 g/dL.\n\nIf the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited based on physician referral at 3 level 1 trauma centers between March 2014 and May 2021. The first patient was enrolled on March 11, 2014 and the last participant was enrolled on May 7, 2021.', 'preAssignmentDetails': "Screening/IC done on 161 patients with a Hgb of ≤9g/dL or whose Hgb was expected to drop below 9g/dL with planned procedures/continued (controlled) bleeding. Randomization assignment occurred once patient's Hgb dropped below 7g/dL. Out of the 161 patient that consented, there were 61 whose Hgb did not drop below 7g/dL and randomization was not performed on. Those 61 patients were considered screen failures, leaving 100 patients who were randomized to either liberal or conservative transfusion."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liberal Transfusion', 'description': 'Transfusion will be done to keep Hgb \\>7 g/dL.'}, {'id': 'BG001', 'title': 'Conservative Transfusion', 'description': 'Transfusion will be done to keep Hgb \\> 5.5 g/dL.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One hundred patients were enrolled and randomized; however, it was noted the day after enrollment for a patient in the liberal group that the patient should not have been enrolled due to a creatinine higher than allowed by the exclusion criteria. The patient was immediately removed from the study and not included in the statistical analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-31', 'size': 896454, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-24T16:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2016-11-17', 'resultsFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-28', 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection', 'timeFrame': 'one year', 'description': 'Deep infection is defined as the need for intravenous antibiotics and/or a return to surgery for debridement. Superficial infection is defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only.'}], 'secondaryOutcomes': [{'measure': 'Combined Secondary Outcomes', 'timeFrame': 'one year', 'description': 'Combined (any) Secondary Outcomes: pulmonary embolism, deep venous thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death.'}, {'measure': 'Musculoskeletal Function Assessment', 'timeFrame': 'one year', 'description': "The Musculoskeletal Function Assessment (MFA) evaluates the health status of patients with musculoskeletal disorders of the extremities, including patients with fractures and soft tissue injuries, repetitive motion disorders, osteoarthritis or rheumatoid arthritis. It describes patient functioning, assesses outcomes of surgical interventions and clinical trials, and monitors patients' functional status over time. The MFA is scored from 0 to 100 with 0 representing no dysfunction. Higher MFA scores/values represent a higher levels of dysfunction or worse outcome."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '38154083', 'type': 'DERIVED', 'citation': 'Mullis BH, Mullis LS, Kempton LB, Virkus W, Slaven JE, Bruggers J. Early Results of Orthopaedic Trauma and Anemia: Conservative Versus Liberal Transfusion Strategy. J Am Acad Orthop Surg. 2024 Mar 1;32(5):228-235. doi: 10.5435/JAAOS-D-23-00235. Epub 2023 Dec 27.'}, {'pmid': '38093439', 'type': 'DERIVED', 'citation': 'Mullis BH, Mullis LS, Kempton LB, Virkus W, Slaven JE, Bruggers J. Orthopaedic Trauma and Anemia: Conservative versus Liberal Transfusion Strategy: A Prospective Randomized Study. J Orthop Trauma. 2024 Jan 1;38(1):18-24. doi: 10.1097/BOT.0000000000002696.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there is a difference in outcomes between liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and conservative transfusion (transfusing when hemoglobin drops below a set lower value number).', 'detailedDescription': "Transfusion of Orthopaedic trauma patients is routinely done in asymptomatic individuals as there is no accepted national standard or recommendations from the American Academy of Orthopaedic Surgeons or the Orthopaedic Trauma Association for what level of anemia is appropriate in an asymptomatic patient. Individual practitioners typically make this decision based on anecdotal experiences and expert opinion. No prospective study has been performed to date to answer this question in this patient population.\n\nThe null hypothesis of this proposed pilot study is that no difference will be seen with a liberal transfusion strategy to keep a patient's hemoglobin above 7 g/dL versus a conservative strategy to keep the patient's hemoglobin above 5.5 g/dL in patients asymptomatic at rest. The primary outcome of this pilot study will be infection; defined as postoperative wound infection (superficial or deep) or other perioperative infection but not surgical site (urinary tract infection or pneumonia). Deep infection is defined as the need for intravenous antibiotics or a return to surgery for debridement. Superficial infection is defined as the use of oral antibiotics only successfully treat a surgical site infection. Secondary outcomes will include pulmonary embolism, deep venous thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death, and the musculoskeletal functional assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Trauma patients admitted to participating hospital with any Orthopaedic injury who have been determined to be stable by the Trauma Service (General Surgery) and are no longer within the resuscitation phase of initial treatment. This is defined as a normal urine output (greater than 0.5 ml/kg/hr) and a systolic blood pressure greater than 90 mmHg for greater than 6 hours without fluid bolus or transfusion during that time\n* Age 18-50\n* Hemoglobin less than 9 g/dL or expected drop below 9 g/dL with planned surgery\n\nExclusion Criteria:\n\n* Pregnant ( urine pregnancy test will be done as standard of care)\n* Prisoner\n* Head injury (Glasgow Coma Scale less than 8 over 48 hours from presentation)\n* Known cardiac (coronary artery disease, atrial fibrillation, stent placement, congestive heart failure), renal (acute or chronic renal insufficiency or failure, defined as having Serum Creatinine \\>1.2 at time of enrollment), liver (Childs C cirrhosis) or pulmonary disease (chronic obstructive pulmonary disease, abnormal pulmonary function tests or history of poor pulmonary function from any cause including acute traumatic conditions such as ARDS)\n* Unlikely to follow up in the surgeon's estimation\n* Sickle Cell Anemia\n* History of cancer\n* Preexisting weakness, paresthesias, deformities, or other conditions which might affect functional outcome in the surgeon's opinion\n* Spinal cord injury\n* Patients with burns expected to require operative treatment\n* COVID positive"}, 'identificationModule': {'nctId': 'NCT02972593', 'acronym': 'ORACL', 'briefTitle': 'ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion', 'orgStudyIdInfo': {'id': '1402557771'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Liberal', 'description': 'Blood and blood products for transfusion. Transfusion will be done to keep Hgb \\>7 g/dL.', 'interventionNames': ['Biological: Blood and blood products for transfusion']}, {'type': 'OTHER', 'label': 'Conservative', 'description': 'Blood and blood products for transfusion. Transfusion will be done to keep Hgb \\> 5.5 g/dL.', 'interventionNames': ['Biological: Blood and blood products for transfusion']}], 'interventions': [{'name': 'Blood and blood products for transfusion', 'type': 'BIOLOGICAL', 'description': "Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb \\>7 g/dL. If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL. If the patient's Hgb does not drop below 7.0 g/dL, randomization will not be done.", 'armGroupLabels': ['Conservative', 'Liberal']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Brian H Mullis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Atlanta Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brian Mullis', 'investigatorAffiliation': 'Indiana University'}}}}