Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00779558
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2008-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Heparin and the Reduction of Thrombosis (HART) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alan.schroeder@hhs.sccgov.org', 'phone': '408 885-5260', 'title': 'Alan Schroeder', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Study Drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour\n\nHeparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo - normal saline infusion', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour\n\nHeparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo - normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days', 'description': 'Echocardiographic evidence of thrombosis while on study drug', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total PRBCs Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour\n\nHeparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo - normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '13', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days to Extubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour\n\nHeparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo - normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac ICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour\n\nHeparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo - normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour\n\nHeparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo - normal saline infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour\n\nHeparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo - normal saline infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour\n\nHeparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo - normal saline infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', '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'}]}}, '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': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-10', 'studyFirstSubmitDate': '2008-10-22', 'resultsFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2008-10-23', 'lastUpdatePostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-10', 'studyFirstPostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombosis', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days', 'description': 'Echocardiographic evidence of thrombosis while on study drug'}], 'secondaryOutcomes': [{'measure': 'Total PRBCs Transfused', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)'}, {'measure': 'Days to Extubation', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)'}, {'measure': 'Cardiac ICU Length of Stay', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)'}, {'measure': 'Need for Antibiotics', 'timeFrame': 'While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thrombosis']}, 'referencesModule': {'references': [{'pmid': '20101197', 'type': 'DERIVED', 'citation': 'Schroeder AR, Axelrod DM, Silverman NH, Rubesova E, Merkel E, Roth SJ. A continuous heparin infusion does not prevent catheter-related thrombosis in infants after cardiac surgery. Pediatr Crit Care Med. 2010 Jul;11(4):489-95. doi: 10.1097/PCC.0b013e3181ce6e29.'}]}, 'descriptionModule': {'briefSummary': 'Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery. This study will answer the question: does a low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline infusion, in patients less than one year of age after cardiac surgery?', 'detailedDescription': "Patients are contacted pre-operatively and their parents consented. The following criteria apply:\n\nInclusion criteria:\n\nAll infants \\< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital\n\nExclusion Criteria:\n\nKnown coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO\n\nRandomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.\n\nThrombosis is demonstrated by echocardiogram or ultrasound performed at\n\n1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.\n\nThe following are calculations for statistical analysis:\n\nSample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All infants \\< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital \\& #xA\n\nExclusion Criteria:\n\n* Known coagulopathy\n* History of clinically significant bleeding (GI, cranial, pulmonary)\n* Need for therapeutic heparinization\n* ECMO"}, 'identificationModule': {'nctId': 'NCT00779558', 'briefTitle': 'Heparin and the Reduction of Thrombosis (HART) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery', 'orgStudyIdInfo': {'id': 'SU-11132007-879'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study drug', 'description': 'Heparin sulfate infusion at 10 units/kg/hour', 'interventionNames': ['Drug: Heparin sulfate infusion at 10 units/kg/hour']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo - normal saline infusion', 'interventionNames': ['Drug: Placebo infusion']}], 'interventions': [{'name': 'Heparin sulfate infusion at 10 units/kg/hour', 'type': 'DRUG', 'otherNames': ['heparin'], 'description': 'Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery', 'armGroupLabels': ['Study drug']}, {'name': 'Placebo infusion', 'type': 'DRUG', 'description': 'Infusion of normal saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Stephen J. Roth M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alan Schroeder', 'investigatorAffiliation': 'Stanford University'}}}}