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

Phase 4

Completed

• Conditions: Heart Defect; Triscupid Atresia

• Registration Number: NCT00182104
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-08
• Study Completion: 2005-07
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-19
• Last Update Posted: 2007-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan

Secondary Outcome Measures

Name	Time	Method
Identify subpopulation of Fontan pts at high risk for TEs
Determine high risk period for TEs in first 2 yrs post Fontan

Trial Locations

Locations (7)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

University of Alberta HSC; 🇨🇦 Edmonton, Alberta, Canada

Sick Children's Hospital; 🇨🇦 Toronto, Ontario, Canada

Hopital Ste-Justine; 🇨🇦 Montreal, Quebec, Canada

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Royal Children's Hospital; 🇦🇺 Parkville, Victoria, Australia