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International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures

This study has been completed.
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University Identifier:
First received: September 9, 2005
Last updated: April 19, 2007
Last verified: April 2007
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.

Condition Intervention Phase
Heart Defect
Triscupid Atresia
Drug: Warfarin vs ASA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan

Secondary Outcome Measures:
  • Identify subpopulation of Fontan pts at high risk for TEs
  • Determine high risk period for TEs in first 2 yrs post Fontan

Estimated Enrollment: 111
Study Start Date: August 1998
Study Completion Date: July 2005

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1. Patient is scheduled to have a Fontan or modified Fontan procedure

Exclusion Criteria:

  1. Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)
  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
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Please refer to this study by its identifier: NCT00182104

Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
University of Alberta HSC
Edmonton, Alberta, Canada, T6G 2R7
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Sick Children's Hospital
Toronto, Ontario, Canada
Canada, Quebec
Hopital Ste-Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
Study Chair: Paul Monagle, MD Royal Children's Hospital, Parkville, Victoria, Australia
Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children
Principal Investigator: Robin Roberts, MD McMaster University