Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00350220
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2006-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Transfusion Strategies in Pediatric Cardiothoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D000080039', 'term': 'Univentricular Heart'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057668', 'term': 'Bloodless Medical and Surgical Procedures'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jill_Cholette@urmc.rochester.edu', 'phone': '585-275-0189', 'title': 'Jill M. Cholette MD', 'organization': 'University of Rochester Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were no limitations to this study. There was 100% compliance with study procedures. There were no adverse events.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High Hemoglobin (Liberal) Group', 'description': 'High Hemoglobin group; goal Hb \\>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Hb (Restrictive) Group', 'description': 'Low Hb transfusion group; RBCs are not transfused unless the Hb \\<9.0 g/dl and clinical indications for transfusion are met.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Arterial Lactate Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Hemoglobin (Liberal) Group', 'description': 'High Hemoglobin group; goal Hb \\>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.'}, {'id': 'OG001', 'title': 'Low Hb (Restrictive) Group', 'description': 'Low Hb transfusion group; RBCs are not transfused unless the Hb \\<9.0 g/dl and clinical indications for transfusion are met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Mean arterial lactate for the first 48 hours post-op.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-01'}, {'type': 'SECONDARY', 'title': 'Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.', 'timeFrame': '3 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Mechanical Ventilation', 'timeFrame': '3 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Oxygen Use', 'timeFrame': '3 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Vasoactive Agent Administration', 'timeFrame': '3 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Volume of Blood Transfused', 'timeFrame': '3 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality Before Hospital Discharge', 'timeFrame': '30 days', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Peak Arterial Lactate Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Hemoglobin (Liberal) Group', 'description': 'High Hemoglobin group; goal Hb \\>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.'}, {'id': 'OG001', 'title': 'Low Hb (Restrictive) Group', 'description': 'Low Hb transfusion group; RBCs are not transfused unless the Hb \\<9.0 g/dl and clinical indications for transfusion are met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Peak arterial lactate level for the 48 hour post-op study period.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Hemoglobin (Liberal) Group', 'description': 'High Hemoglobin group; goal Hb \\>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.'}, {'id': 'FG001', 'title': 'Low Hb (Restrictive) Group', 'description': 'Low Hb transfusion group; RBCs are not transfused unless the Hb \\<9.0 g/dl and clinical indications for transfusion are met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Hemoglobin (Liberal) Group', 'description': 'High Hemoglobin group; goal Hb \\>13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.'}, {'id': 'BG001', 'title': 'Low Hb (Restrictive) Group', 'description': 'Low Hb transfusion group; RBCs are not transfused unless the Hb \\<9.0 g/dl and clinical indications for transfusion are met.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'subjects under 8 years of age included', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '2.25', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2006-07-05', 'resultsFirstSubmitDate': '2010-01-19', 'studyFirstSubmitQcDate': '2006-07-05', 'lastUpdatePostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-11', 'studyFirstPostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Arterial Lactate Level', 'timeFrame': '48 hours', 'description': 'Mean arterial lactate for the first 48 hours post-op.'}, {'measure': 'Peak Arterial Lactate Level', 'timeFrame': '48 hours', 'description': 'Peak arterial lactate level for the 48 hour post-op study period.'}], 'secondaryOutcomes': [{'measure': 'Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.', 'timeFrame': '3 days'}, {'measure': 'Length of Mechanical Ventilation', 'timeFrame': '3 days'}, {'measure': 'Length of Oxygen Use', 'timeFrame': '3 days'}, {'measure': 'Length of Vasoactive Agent Administration', 'timeFrame': '3 days'}, {'measure': 'Volume of Blood Transfused', 'timeFrame': '3 days'}, {'measure': 'Mortality Before Hospital Discharge', 'timeFrame': '30 days'}]}, 'conditionsModule': {'keywords': ['Single ventricle', 'Bidirectional Glenn', 'Fontan', 'Congenital cardiac disease', 'Red blood cell transfusion', 'oxygen utilization', 'lactate level', 'hemoglobin level'], 'conditions': ['Congenital Heart Disease']}, '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown.', 'detailedDescription': 'Objective: To compare mean post-operative arterial lactate levels, oxygen utilization, and outcome measures in pediatric patients undergoing cavopulmonary connection managed with two different red blood cell transfusion strategies.\n\nMethods: We propose a prospective, randomized clinical trial of sixty-six pediatric patients with cyanotic, complex congenital cardiac disease undergoing cavopulmonary connection as their operative repair. Thirty-three patients will be randomly assigned to a low Hb strategy of transfusion, in which red cells are transfused if the hemoglobin concentration falls below 9.0 g/dL, and hemoglobin concentrations are maintained about 8.5 g/dL. Thirty-three additional patients will be randomly assigned to the high Hb transfusion strategy, where red cells are transfused if the hemoglobin concentration falls below 13.0 g/dL, and hemoglobin concentrations are maintained about 12.5 g/dL. The primary endpoint will be comparison of mean arterial lactate levels from 8 to 72 hours post-operatively. The secondary endpoints will be oxygen utilization reflected by the arterio-venous oxygen difference (AV-difference) and arterio-cerebral oxygen difference (AC-difference). Measures of oxygen utilization will be derived from arterial oxygen saturation (SaO2), mixed venous oxygen saturation (SvO2), and cerebral oxygen saturation (ScO2) collected at various time points throughout the study. Tertiary outcome measures will be length of mechanical ventilation, length of oxygen use and of vasoactive agent administration, length pediatric cardiac intensive care unit (PCICU) admission, volume of blood transfused, and mortality. Data from each group will be compared using analysis of variance to assess for the presence of a difference between the two transfusion strategies. If a significant difference between the two groups exists, T-tests will be performed to compare data points between each group to assess for a significant difference.\n\nHypothesis: A more restrictive (low Hb) strategy of red cell transfusion will be as effective as, and possibly superior to, the historical (high Hb) approach. Allowing a lower Hb concentration will decrease RBC donor exposure and may decrease the known complications of RBC transfusions. We postulate that no significant difference will exist between the two transfusion groups in regards to hemodynamic and cardiopulmonary status (as evidenced by mean lactate levels) and oxygen utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4 months to 6.99 years of age\n* surgical candidates for cavopulmonary connection\n* English speaking\n\nExclusion Criteria:\n\n* presence of known bleeding disorder\n* presence of known coagulopathy\n* age \\< 4 months\n* age \\> 7 years\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT00350220', 'briefTitle': 'Transfusion Strategies in Pediatric Cardiothoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.', 'orgStudyIdInfo': {'id': '12408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'High Hemoglobin group; goal Hb \\>13g/dl. 10cc/kg RBCs are transfused for any hemoglobin value under 13g/dl regardless whether clinical indication for transfusion exists.', 'interventionNames': ['Other: transfusion strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Low Hb transfusion group; goal to not transfuse unless the Hb \\<9.0 g/dl. 10cc/kg RBCs are transfused only if the Hemoglobin is under 9.0g/dl and clinical indications for transfusion exist.', 'interventionNames': ['Other: Low Hb transfusion group']}], 'interventions': [{'name': 'transfusion strategy', 'type': 'OTHER', 'description': 'For the High Hb group; transfusions will be given to keep the Hb \\>13.0 g/dl', 'armGroupLabels': ['1']}, {'name': 'Low Hb transfusion group', 'type': 'OTHER', 'description': 'RBCs will not be transfused unless the Hb \\< 9.0 g/dl', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Jill M Cholette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'jill cholette', 'investigatorAffiliation': 'University of Rochester'}}}}