Status:
COMPLETED
International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
Conditions:
Heart Defect
Triscupid Atresia
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
Eligibility Criteria
Inclusion
- 1\. Patient is scheduled to have a Fontan or modified Fontan procedure
Exclusion
- Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)
- Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.
- Inability to supervise therapy due to social or geographical reasons.
- Pregnancy or potential pregnancy during study period
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00182104
Start Date
August 1 1998
End Date
July 1 2005
Last Update
April 20 2007
Active Locations (7)
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1
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
2
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
3
University of Alberta HSC
Edmonton, Alberta, Canada, T6G 2R7
4
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4