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Completed

NCT Number: NCT00182104

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

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

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Key information

Conditions

Heart Defect Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Thrombosis Triscupid Atresia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Children's Hospital, Parkville, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Warfarin vs ASA

Drug

Primary outcomes

  1. Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan

Secondary outcomes

  1. Identify subpopulation of Fontan pts at high risk for TEs

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

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Official study title

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

Important dates

Study start
1998
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Apr 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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