Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-30 @ 5:07 AM
Study NCT ID:
NCT05076604
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Microplegia on Transfusion Rates After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002314', 'term': 'Cardioplegic Solutions'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schillm@wustl.edu', 'phone': '3147470707', 'title': 'Matthew Schill', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Cardioplegia', 'description': '4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nCardioplegia Solution: The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 50, 'seriousNumAtRisk': 157, 'deathsNumAffected': 11, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Microplegia', 'description': 'Nondiluted microplegia consists of all parts human blood.\n\nMicroplegic Solution No. 1: The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 56, 'seriousNumAtRisk': 157, 'deathsNumAffected': 7, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Pneumonia', 'notes': 'STS Definition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 47}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Postoperative Acute Kidney Injury', 'notes': 'Per STS Definition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative Hemodialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolonged Ventilation', 'notes': 'STS Definition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tracheostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reintervention due to MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative ECMO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraoperative and Postoperative Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardioplegia', 'description': '4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nCardioplegia Solution: The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.'}, {'id': 'OG001', 'title': 'Microplegia', 'description': 'Nondiluted microplegia consists of all parts human blood.\n\nMicroplegic Solution No. 1: The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.'}], 'classes': [{'title': 'Intraoperative Red Blood Cell Transfusion (units)', 'categories': [{'measurements': [{'value': '2.43', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'Postoperative Red Blood Cell Transfusion (units)', 'categories': [{'measurements': [{'value': '4.42', 'spread': '6.06', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '4.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.354', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Intraoperative packed red blood cell transfusion', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.314', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Postoperative red blood cell transfusion', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative (time in operating room), Postoperative (from transfer from operating room to intensive care unit to 30 days)', 'description': 'To determine if use of microplegia results in less peri-operative transfusions compared to diluted 4:1 cardioplegia.', 'unitOfMeasure': 'units of blood per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardioplegia', 'description': '4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nCardioplegia Solution: The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.'}, {'id': 'FG001', 'title': 'Microplegia', 'description': 'Nondiluted microplegia consists of all parts human blood.\n\nMicroplegic Solution No. 1: The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '31'}]}]}], 'recruitmentDetails': 'Participants were recruited at a tertiary care academic medical center.', 'preAssignmentDetails': 'All enrolled patients were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardioplegia', 'description': '4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nCardioplegia Solution: The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.'}, {'id': 'BG001', 'title': 'Microplegia', 'description': 'Nondiluted microplegia consists of all parts human blood.\n\nMicroplegic Solution No. 1: The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '60.4', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '186', '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': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', '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': '3', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '287', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-25', 'size': 380442, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-31T14:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2021-10-04', 'resultsFirstSubmitDate': '2024-06-01', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-16', 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative and Postoperative Transfusions', 'timeFrame': 'Intraoperative (time in operating room), Postoperative (from transfer from operating room to intensive care unit to 30 days)', 'description': 'To determine if use of microplegia results in less peri-operative transfusions compared to diluted 4:1 cardioplegia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Disease', 'Mitral Valve Disease']}, 'referencesModule': {'references': [{'pmid': '7253686', 'type': 'BACKGROUND', 'citation': 'Follette DM, Fey K, Buckberg GD, Helly JJ Jr, Steed DL, Foglia RP, Maloney JV Jr. Reducing postischemic damage by temporary modification of reperfusate calcium, potassium, pH, and osmolarity. J Thorac Cardiovasc Surg. 1981 Aug;82(2):221-38.'}, {'pmid': '6387286', 'type': 'BACKGROUND', 'citation': 'Fremes SE, Christakis GT, Weisel RD, Mickle DA, Madonik MM, Ivanov J, Harding R, Seawright SJ, Houle S, McLaughlin PR, et al. A clinical trial of blood and crystalloid cardioplegia. J Thorac Cardiovasc Surg. 1984 Nov;88(5 Pt 1):726-41.'}, {'pmid': '16820596', 'type': 'BACKGROUND', 'citation': 'Guru V, Omura J, Alghamdi AA, Weisel R, Fremes SE. Is blood superior to crystalloid cardioplegia? A meta-analysis of randomized clinical trials. Circulation. 2006 Jul 4;114(1 Suppl):I331-8. doi: 10.1161/CIRCULATIONAHA.105.001644.'}, {'pmid': '16637518', 'type': 'BACKGROUND', 'citation': 'McCann UG 2nd, Lutz CJ, Picone AL, Searles B, Gatto LA, Dilip KA, Nieman GF. Whole blood cardioplegia (minicardioplegia) reduces myocardial edema after ischemic injury and cardiopulmonary bypass. J Extra Corpor Technol. 2006 Mar;38(1):14-21.'}, {'pmid': '23608252', 'type': 'BACKGROUND', 'citation': 'Algarni KD, Weisel RD, Caldarone CA, Maganti M, Tsang K, Yau TM. Microplegia during coronary artery bypass grafting was associated with less low cardiac output syndrome: a propensity-matched comparison. Ann Thorac Surg. 2013 May;95(5):1532-8. doi: 10.1016/j.athoracsur.2012.09.056.'}, {'pmid': '22795715', 'type': 'BACKGROUND', 'citation': 'Onorati F, Santini F, Dandale R, Ucci G, Pechlivanidis K, Menon T, Chiominto B, Mazzucco A, Faggian G. "Polarizing" microplegia improves cardiac cycle efficiency after CABG for unstable angina. Int J Cardiol. 2013 Sep 10;167(6):2739-46. doi: 10.1016/j.ijcard.2012.06.099. Epub 2012 Jul 12.'}, {'pmid': '17998460', 'type': 'BACKGROUND', 'citation': 'Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.'}, {'pmid': '14771796', 'type': 'RESULT', 'citation': 'BIGELOW WG, LINDSAY WK, GREENWOOD WF. Hypothermia; its possible role in cardiac surgery: an investigation of factors governing survival in dogs at low body temperatures. Ann Surg. 1950 Nov;132(5):849-66. doi: 10.1097/00000658-195011000-00001. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital.\n\nCardioplegia refers to the method of stopping (arresting) the heart in order to perform heart surgery. However, cardioplegia has also come to refer to the solution to achieve cardiac arrest as well as the machinery in which to deliver the solution. This study will investigate our current Standard Cardioplegia (diluted 4:1 blood cardioplegia) versus Microplegia (undiluted blood cardioplegia) to determine if Microplegia reduces peri-operative blood transfusion rates as compared to Standard Cardioplegia. All forms of cardioplegia will be delivered using the MPS2 Microplegia delivery machine by Quest Medical, Inc.\n\nPatients will be randomized to receive undiluted microplegia or standard 4:1 cardioplegia. The patient and the surgeon will be blinded to the randomization.\n\nPatients will be followed for 30 days post-operatively (or until their initial standard of care post-operative follow up visit with cardiac surgery if that appointment falls outside of the 30 day post-operative window) for the development of any adverse events as well as documentation of blood products given.\n\nWe will draw one tube of blood for troponin levels at four time points; 1 draw before surgery (this may be done during the intraoperative period), and 3 draws post-operatively: ICU arrival, 12 hours post-ICU arrival and 24 hours post-ICU arrival. This is to closely monitor the patient for any heart tissue injury.', 'detailedDescription': 'Cardioplegia was first introduced as a method to protect the heart during cardiac surgery in the 1950s (1). Initially, it consisted of a crystalloid solution and in the 1970s Follette and colleagues proposed that blood was the best mode of delivery of cardioplegia as it is rich in nutrients and oxygen (2). Blood has better osmotic, buffering, and antioxidant qualities that are needed by ischemic myocardium. More recent studies comparing blood and crystalloid cardioplegias showed that there was less cardiac edema, and recovery of ventricular function was more rapid with blood based cardioplegia (3). A meta-analysis of over 5000 patients corroborated these findings and showed that blood based cardioplegia reduced the incidence of postoperative low cardiac output syndrome and was associated with less myocardial damage (4).\n\nStandard diluted blood cardioplegia can also be modified to undiluted blood cardioplegia also known as microplegia. To compare the cardioprotection of 4:1 blood:crystalloid cardioplegia to microplegia, McCann et al randomized 20 pigs to either group. Cardiac edema was measured using histologic morphometrics and echocardiogram. It was noted that both edema percentage and left ventricular mass were significantly more decreased in the microplegia group. Furthermore, all animals receiving microplegia were successfully weaned off cardiopulmonary bypass, whereas only 40% of those receiving standard cardioplegia were successfully weaned (5).\n\nMore recently, Algarni et al. showed decreased prevalence of low cardiac output syndrome in patients who received microplegia (n=2,630) (6). Another study compared microplegia and standard cardioplegia in patients undergoing coronary artery bypass grafting and found that the microplegia group had lower troponin levels during the post-operative course. Moreover, microplegia resulted in lower transfusion rates and decreased length of hospital stay (7).\n\nA high rate of patients undergoing cardiac surgery require red blood cell transfusions (RBC). Red blood cell transfusions are strongly associated with both infection and ischemic postoperative morbidity, length of stay, increased early and late mortality, and overall hospital costs (8). Given that previous studies have shown that microplegia is associated with less transfusions, it would be reasonable to incorporate this into practice at Washington University.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are to undergo non-emergent cardiac surgery\n* \\>18 years of age\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* History of endocarditis\n* Dialysis-dependent renal failure\n* Currently on pre-operative mechanical circulatory support (i.e. ECMO, LVAD or intra-aortic balloon pump \\[IABP\\])\n* Contraindication to receiving a blood transfusion (i.e. Jehovah's Witness)\n* Emergency procedures"}, 'identificationModule': {'nctId': 'NCT05076604', 'briefTitle': 'Effects of Microplegia on Transfusion Rates After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Effects of Microplegia on Transfusion Rates After Cardiac Surgery: A Randomized Prospective Analysis', 'orgStudyIdInfo': {'id': '201801103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cardioplegia', 'description': '4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.', 'interventionNames': ['Drug: Cardioplegia Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Microplegia', 'description': 'Nondiluted microplegia consists of all parts human blood.', 'interventionNames': ['Drug: Microplegic Solution No. 1']}], 'interventions': [{'name': 'Cardioplegia Solution', 'type': 'DRUG', 'description': 'The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.', 'armGroupLabels': ['Cardioplegia']}, {'name': 'Microplegic Solution No. 1', 'type': 'DRUG', 'description': 'The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:\n\nInduction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume\n\nMaintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume\n\nSubjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.\n\n4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.\n\nNondiluted microplegia consists of all parts human blood.', 'armGroupLabels': ['Microplegia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Spencer J Melby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quest Medical, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}