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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: Heart and Stroke Foundation of Canada
• Treatments: Warfarin

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