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

Hamilton Health Sciences (HHS)

Status and phase: Completed; Phase 4

Conditions: Heart Defect; Triscupid Atresia

Treatments: Drug: Warfarin vs ASA

Study type: Interventional

Funder types: Other

Identifiers

NCT00182104

CTMG-1998-Fontan

Hearth and Stroke grant 1998

Details and patient eligibility

About

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

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)