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

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

Sponsors

Lead sponsor: Hamilton Health Sciences Corporation

Collaborator: Heart and Stroke Foundation of Canada

Source McMaster University
Brief Summary

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

Overall Status Completed
Start Date August 1998
Completion Date July 2005
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
Secondary Outcome
Measure Time Frame
Identify subpopulation of Fontan pts at high risk for TEs
Determine high risk period for TEs in first 2 yrs post Fontan
Enrollment 111
Condition
Intervention

Intervention type: Drug

Intervention name: Warfarin vs ASA

Eligibility

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
Royal Children's Hospital | Parkville, Victoria, 3052, Australia
Alberta Children's Hospital | Calgary, Alberta, T2T 5C7, Canada
University of Alberta HSC | Edmonton, Alberta, T6G 2R7, Canada
BC Children's Hospital | Vancouver, British Columbia, V6H 3V4, Canada
IWK Health Centre | Halifax, Nova Scotia, B3J 3G9, Canada
Sick Children's Hospital | Toronto, Ontario, Canada
Hopital Ste-Justine | Montreal, Quebec, H3T 1C5, Canada
Location Countries

Australia

Canada

Verification Date

April 2007

Keywords
Has Expanded Access No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov