Trial | NCT00182104  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    111
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
Study Started
Aug 31
1998
Study Completion
Jul 31
2005
Last Update
Apr 20
2007
Estimate

Drug Warfarin vs ASA

Criteria 

Inclusion Criteria:

1. Patient is scheduled to have a Fontan or modified Fontan procedure

Exclusion Criteria:

Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)
Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.
Inability to supervise therapy due to social or geographical reasons.
Pregnancy or potential pregnancy during study period
No Results Posted