- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00182104
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
-
-
Victoria
-
Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
-
-
-
-
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:
- 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
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.
Collaborators
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
- McCrindle BW, Manlhiot C, Cochrane A, Roberts R, Hughes M, Szechtman B, Weintraub R, Andrew M, Monagle P; Fontan Anticoagulation Study Group. Factors associated with thrombotic complications after the Fontan procedure: a secondary analysis of a multicenter, randomized trial of primary thromboprophylaxis for 2 years after the Fontan procedure. J Am Coll Cardiol. 2013 Jan 22;61(3):346-53. doi: 10.1016/j.jacc.2012.08.1023. Epub 2012 Dec 12.
- Monagle P, Cochrane A, Roberts R, Manlhiot C, Weintraub R, Szechtman B, Hughes M, Andrew M, McCrindle BW; Fontan Anticoagulation Study Group. A multicenter, randomized trial comparing heparin/warfarin and acetylsalicylic acid as primary thromboprophylaxis for 2 years after the Fontan procedure in children. J Am Coll Cardiol. 2011 Aug 2;58(6):645-51. doi: 10.1016/j.jacc.2011.01.061.
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
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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