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

April 19, 2007 updated by: Hamilton Health Sciences Corporation

An 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

111

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children's Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 2R7
        • University of Alberta HSC
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • BC Children's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • IWK Health Centre
    • Ontario
      • Toronto, Ontario, Canada
        • Sick Children's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Hôpital Ste-Justine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan

Secondary Outcome Measures

Outcome Measure
Identify subpopulation of Fontan pts at high risk for TEs
Determine high risk period for TEs in first 2 yrs post Fontan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Heart and Stroke Foundation of Canada

Investigators

  • Study Chair: Paul Monagle, MD, Royal Children's Hospital, Parkville, Victoria, Australia
  • Principal Investigator: Brian McCrindle, MD, The Hospital for Sick Children
  • Principal Investigator: Robin Roberts, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

April 20, 2007

Last Update Submitted That Met QC Criteria

April 19, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMG-1998-Fontan
  • Hearth and Stroke grant 1998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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