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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00182104

Enrollment

111

Registered

2005-09-16

Start date

1998-08-31

Completion date

2005-07-31

Last updated

2007-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Defect, Triscupid Atresia

Keywords

Fontan procedure, Anticoagulation, Thrombosis, Thromboembolism, Prevention

Brief summary

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

Interventions

DRUGWarfarin vs ASA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan	—

Secondary

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	—

Countries

Australia, Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026