An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Sponsor study identifier
Secondary identifiers
interventional
111
2 countries
7
Study Start
August 1998
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
July 2005
Actual (reported)Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1998
Date type not reportedThis date has not been verified as actual or estimated.
July 2005
Actual (reported)September 9, 2005
Actual (reported)September 16, 2005
Actual (reported)Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
Identify subpopulation of Fontan pts at high risk for TEs
Determine high risk period for TEs in first 2 yrs post Fontan
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7, Canada
University of Alberta HSC
Edmonton, Alberta, T6G 2R7, Canada
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9, Canada
Sick Children's Hospital
Toronto, Ontario, Canada
Hopital Ste-Justine
Montreal, Quebec, H3T 1C5, Canada
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.
Paul Monagle, MD
Royal Children's Hospital, Parkville, Victoria, Australia
Brian McCrindle, MD
The Hospital for Sick Children
Robin Roberts, MD
McMaster University
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
August 1998
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
July 2005
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
April 20, 2007
Record last verified: 2007-04
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Source: ClinicalTrials.gov.
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