Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT00182104
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-19', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan'}], 'secondaryOutcomes': [{'measure': 'Identify subpopulation of Fontan pts at high risk for TEs'}, {'measure': 'Determine high risk period for TEs in first 2 yrs post Fontan'}]}, 'conditionsModule': {'keywords': ['Fontan procedure', 'Anticoagulation', 'Thrombosis', 'Thromboembolism', 'Prevention'], 'conditions': ['Heart Defect', 'Triscupid Atresia']}, 'referencesModule': {'references': [{'pmid': '23246393', 'type': 'DERIVED', 'citation': 'McCrindle BW, Manlhiot C, Cochrane A, Roberts R, Hughes M, Szechtman B, Weintraub R, Andrew M, Monagle P; Fontan Anticoagulation Study Group. Factors associated with thrombotic complications after the Fontan procedure: a secondary analysis of a multicenter, randomized trial of primary thromboprophylaxis for 2 years after the Fontan procedure. J Am Coll Cardiol. 2013 Jan 22;61(3):346-53. doi: 10.1016/j.jacc.2012.08.1023. Epub 2012 Dec 12.'}, {'pmid': '21798429', 'type': 'DERIVED', 'citation': 'Monagle P, Cochrane A, Roberts R, Manlhiot C, Weintraub R, Szechtman B, Hughes M, Andrew M, McCrindle BW; Fontan Anticoagulation Study Group. A multicenter, randomized trial comparing heparin/warfarin and acetylsalicylic acid as primary thromboprophylaxis for 2 years after the Fontan procedure in children. J Am Coll Cardiol. 2011 Aug 2;58(6):645-51. doi: 10.1016/j.jacc.2011.01.061.'}]}, 'descriptionModule': {'briefSummary': 'Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patient is scheduled to have a Fontan or modified Fontan procedure\n\nExclusion Criteria:\n\n1. Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)\n2. Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.\n3. Inability to supervise therapy due to social or geographical reasons.\n4. Pregnancy or potential pregnancy during study period'}, 'identificationModule': {'nctId': 'NCT00182104', 'briefTitle': 'International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures', 'orgStudyIdInfo': {'id': 'CTMG-1998-Fontan'}, 'secondaryIdInfos': [{'id': 'Hearth and Stroke grant 1998'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Warfarin vs ASA', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children's Hospital", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'T2T 5C7', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2R7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta HSC', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3J 3G9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Sick Children's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Ste-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Paul Monagle, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Royal Children's Hospital, Parkville, Victoria, Australia"}, {'name': 'Brian McCrindle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}, {'name': 'Robin Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}]}}}