Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-31 @ 4:27 PM
Study NCT ID:
NCT01623193
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2012-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2016-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2012-06-15', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood transfusion', 'timeFrame': '30 days', 'description': 'Number of units of packed red blood cells transfused'}, {'measure': 'Intra-op diastolic function', 'timeFrame': 'day 1', 'description': 'Left ventricular chamber stiffness constant measured by conductance catheter in the operating room'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 day', 'description': 'Mortality'}, {'measure': 'Duration of Ventilation', 'timeFrame': '30 day'}, {'measure': 'Lentgh of stay ICU', 'timeFrame': '30 days'}, {'measure': 'Length of stay - hospital', 'timeFrame': '30 day'}, {'measure': 'Other blood product administration', 'timeFrame': '30 day'}, {'measure': 'Hgb - arrival ICU', 'timeFrame': 'day 1'}, {'measure': 'Hgb - prior to Discharge', 'timeFrame': '30 days'}, {'measure': 'Lowest post op Hgb', 'timeFrame': '30 days'}, {'measure': 'Volume of crystalloid delivered in cardioplegia', 'timeFrame': 'day 1'}, {'measure': 'Fluid balance', 'timeFrame': '30 d'}, {'measure': 'Reoperation rate for bleeding', 'timeFrame': '30 days'}, {'measure': 'Inotrope score', 'timeFrame': '30 day', 'description': 'Score incorporating amount and number of inotropes administered'}, {'measure': 'Low output syndrome', 'timeFrame': '30 days'}, {'measure': 'Troponin', 'timeFrame': '24 hours post op'}, {'measure': 'Infection', 'timeFrame': '30 days', 'description': 'Composite according to standardized definitions'}, {'measure': 'intra-op Ventricular function', 'timeFrame': 'day 1', 'description': 'as determined by conductance catheter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardioplegia', 'Blood transfusion', 'Cardiac function', 'Myocardial edema', 'Coronary artery disease', 'Valve disease'], 'conditions': ['Coronary Artery Disease', 'Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': 'This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia to more dilute 4:1 blood cardioplegia during cardiac surgery. The hypothesis is that all-blood cardioplegia will be associated with less blood transfusion and better cardiac function.', 'detailedDescription': 'This is a single centre randomized, double blind, 2 arm, parallel group pilot study comparing all-blood cardioplegia to 4:1 blood cardioplegia in patients undergoing cardiac surgery. This pilot study will support the design of a larger multicentre trial.\n\nSubjects undergoing cardiac surgery will be randomized to receive either standard of care (4:1) or all-blood cardioplegia for myocardial protection. Neither of these cardioplegia approaches would be considered investigational. Each is in use at numerous cardiac surgical centres around the world. The cardioplegia will be delivered using the Quest medical MPS system which is a Health Canada Approved device.\n\nClinical endpoints will be evalauted (rate of blood transtransfusion, ICU stay, etc…). In a subset of subjects who meet specific criteria, ventricular function will be evaluated in the operating room using the CD Leycom INCA conductance catheter system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients (male and female) undergoing isolated coronary artery bypass grafting,\n* isolated aortic or mitral repair or replacement, and\n* combined aortic or mitral valve repair or replacement and\n* coronary bypass grafting\n\nExclusion Criteria:\n\n* reoperation,\n* endocarditis,\n* dialysis dependant renal failure,\n* pre-operative ECMO or LVAD support,\n* contraindication to blood transfusion (ie. Jehovah's Witness), and\n* use of irreversible anti-platelet (other than ASA) and anticoagulant agents within 48h (ie. plavix, dabigitran, GpIIb/IIIa inhibitors, argatroban)."}, 'identificationModule': {'nctId': 'NCT01623193', 'acronym': 'ABC', 'briefTitle': 'The ABC Trial Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery? A Single Centre Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery', 'orgStudyIdInfo': {'id': 'ABC Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery', 'interventionNames': ['Procedure: Standard cardioplegia']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients receive all-blood cardiolpegia for myocardial protection during surgery', 'interventionNames': ['Other: All-blood cardioplegia']}], 'interventions': [{'name': 'All-blood cardioplegia', 'type': 'OTHER', 'description': 'The treatment group will receive all-blood cardioplegia for myocardial protection during surgery', 'armGroupLabels': ['Treatment']}, {'name': 'Standard cardioplegia', 'type': 'PROCEDURE', 'description': 'This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Capital Health', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': "Stacy O'Blenes, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dalhousie University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pam Trenholm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pam Trenholm', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}