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

Heart Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182104
• Other study ID #: CTMG-1998-Fontan
• Secondary ID: Hearth and Strok
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: April 19, 2007
• Start date: August 1998
• Est. completion date: July 2005

Study information

• Verified date: April 2007
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Defect
• Triscupid Atresia

Intervention

Drug:
• Warfarin vs ASA

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Parkville	Victoria
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	University of Alberta HSC	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Hopital Ste-Justine	Montreal	Quebec
Canada	Sick Children's Hospital	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Heart and Stroke Foundation of Canada

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
Secondary	Identify subpopulation of Fontan pts at high risk for TEs
Secondary	Determine high risk period for TEs in first 2 yrs post Fontan