International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
NCT ID: NCT00182104
Last Updated: 2007-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
111 participants
INTERVENTIONAL
1998-08-31
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Warfarin vs ASA
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.
3. Inability to supervise therapy due to social or geographical reasons.
4. Pregnancy or potential pregnancy during study period
ALL
No
Sponsors
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Heart and Stroke Foundation of Canada
OTHER
Hamilton Health Sciences Corporation
OTHER
Principal Investigators
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Paul Monagle, MD
Role: STUDY_CHAIR
Royal Children's Hospital, Parkville, Victoria, Australia
Brian McCrindle, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Robin Roberts, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Royal Children's Hospital
Parkville, Victoria, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta HSC
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Sick Children's Hospital
Toronto, Ontario, Canada
Hopital Ste-Justine
Montreal, Quebec, Canada
Countries
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References
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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.
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.
Other Identifiers
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Hearth and Stroke grant 1998
Identifier Type: -
Identifier Source: secondary_id
CTMG-1998-Fontan
Identifier Type: -
Identifier Source: org_study_id