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

Summary

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

Timeline

Start

1998-08

Primary completion

—

Completion

2005-07

Outcome

Missed primary endpoint

paper Cumulative risk of thrombosis was persistent but varying and similar for both groups (p = 0.45). PMID 21798429 ↗

paper There was no significant difference between ASA and heparin/warfarin as primary thromboprophylaxis in the first 2 years after Fontan surgery. PMID 21798429 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	5 mg/kg	—
Subject	Warfarin	Small molecule	—	—

Indications