Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 7:24 PM
Study NCT ID:
NCT00126334
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2005-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-20', 'studyFirstSubmitDate': '2005-08-02', 'studyFirstSubmitQcDate': '2005-08-02', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital death', 'timeFrame': 'In-hospital'}, {'measure': 'Recurrent myocardial infarction (MI)', 'timeFrame': 'In-hospital'}, {'measure': 'New or worsening heart failure', 'timeFrame': 'In-hospital'}], 'secondaryOutcomes': [{'measure': 'Critical Care Unit (CCU) length of stay', 'timeFrame': 'In-hospital'}, {'measure': 'Length of hospitalization', 'timeFrame': 'In-hospital'}, {'measure': 'Death or recurrent MI at hospital discharge and 30 days', 'timeFrame': '30 days'}, {'measure': 'Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days', 'timeFrame': '30 days'}, {'measure': 'Death at 30 days', 'timeFrame': '30 days'}, {'measure': 'In-hospital recurrent ischemia', 'timeFrame': 'In-hospital'}, {'measure': 'In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia', 'timeFrame': 'In-hospital'}, {'measure': 'Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL)', 'timeFrame': 'In-hospitall'}, {'measure': 'Number of transfusions received per patient', 'timeFrame': 'In-hospital'}, {'measure': 'Proportion of patients receiving at least one transfusion', 'timeFrame': 'In-hospital'}, {'measure': 'Mean daily hematocrit', 'timeFrame': 'In-hospital'}, {'measure': 'Transfusion-related reactions', 'timeFrame': 'In-hospital'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial Infarction', 'Anemia', 'Erythrocyte Transfusion'], 'conditions': ['Myocardial Infarction', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '41114449', 'type': 'DERIVED', 'citation': 'Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.'}, {'pmid': '34932836', 'type': 'DERIVED', 'citation': 'Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.', 'detailedDescription': 'The current standard of care for patients with heart attacks is to transfuse red blood cells when the hematocrit (red blood cell count) drops below 30 percent. However, there is little scientific basis for this current standard, and recent research has demonstrated that it is safe to allow the hematocrit (red blood cell count) to drop significantly lower in severely ill medical patients and in patients with heart disease undergoing major surgery. The investigators therefore propose this pilot trial to begin to determine whether or not it is safe to apply a more conservative blood transfusion strategy to patients with heart attacks.\n\nIn this study, patients who are within 72 hours of the onset of a heart attack and who are anemic (have a low red blood cell count) will be randomly assigned to one of two transfusion strategies while they are in the hospital: a liberal strategy of transfusing blood when the hematocrit falls below 30 percent (the current standard) or a conservative strategy of transfusing blood only when the hematocrit falls below 24 percent. It will then be determined which group fares better over the next 30 days.\n\nThe plan is to enroll 92 patients in this pilot trial in order to allow the researchers to plan for a much larger, definitive trial of this important question. It is anticipated that the conservative transfusion strategy will be similar to the standard (liberal) strategy in terms of patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll of the following must be present:\n\n* Acute myocardial infarction with presentation within 72 hours of randomization (acute myocardial infarction is defined as ischemic-type chest discomfort lasting at least 30 minutes associated with creatinine kinase MB (CKMB) or troponin \\>upper limit of normal \\[ULN\\])\n* Admission to CCU\n* Hematocrit .30 or less\n* Written, informed consent\n\nExclusion Criteria:\n\n* Inability or unwillingness to receive red cell transfusions\n* Active bleeding (overt blood loss accompanied by a decrease in hematocrit of at least 5% in the preceding 12 hours)\n* Receipt of red cell transfusion within 7 days of randomization\n* Prior severe transfusion reaction\n* Pregnancy\n* Imminent death\n* Decision to provide limited care\n* Age \\<21\n* Participation in another clinical trial in which blood transfusion is a requirement or a component of a primary or secondary endpoint\n* Previous participation in the CRIT Pilot'}, 'identificationModule': {'nctId': 'NCT00126334', 'acronym': 'CRIT', 'briefTitle': 'Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'orgStudyIdInfo': {'id': '2003-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Liberal transfusion threshold', 'interventionNames': ['Procedure: Packed Red Blood Cell Transfusion']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Conservative transfusion threshold', 'interventionNames': ['Procedure: Packed Red Blood Cell Transfusion']}], 'interventions': [{'name': 'Packed Red Blood Cell Transfusion', 'type': 'PROCEDURE', 'description': 'transfusion of 1 unit of PRBCs', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington VA Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Howard A Cooper, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medstar Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'Dr. Neil Weissman', 'oldOrganization': 'Medstar Research Institute'}}}}