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

Phase 4CompletedNCT00182104

Hamilton Health Sciences Corporation111 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

111

Conditions

Heart Defect Triscupid Atresia

Interventions

Warfarin vs ASADRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (7)

Royal Children's Hospital

Parkville, Victoria, Australia

Alberta Children's Hospital

Calgary, Alberta, Canada

University of Alberta HSC

Edmonton, Alberta, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan

Secondary Outcomes

Identify subpopulation of Fontan pts at high risk for TEs

Determine high risk period for TEs in first 2 yrs post Fontan

Data from ClinicalTrials.gov

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