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

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ClinicalTrials.gov Identifier: NCT00182104
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 20, 2007
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University

Brief Summary:
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.

Condition or disease Intervention/treatment Phase
Heart Defect Triscupid Atresia Drug: Warfarin vs ASA Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Study Start Date : August 1998
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Warfarin
U.S. FDA Resources




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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182104


Locations
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
Investigators
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