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CompletedNCT00182104Updated Apr 20, 2007

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

A Phase 4 interventional study of Warfarin vs ASA in Heart Defect and Triscupid Atresia, sponsored by Hamilton Health Sciences Corporation. Completed at 7 sites in 2 countries. Per ClinicalTrials.gov, last updated 2007-04-20.

Sponsored by Hamilton Health Sciences Corporation · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
111
Allocation
Randomized
Sex
All
01

Study summary

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

02

Conditions studied

  • Heart Defect
  • Triscupid Atresia

Keywords

  • Fontan procedure
  • Anticoagulation
  • Thrombosis
  • Thromboembolism
  • Prevention
03

In context

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient is scheduled to have a Fontan or modified Fontan procedure

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
111 participants

Interventions

  • DrugWarfarin vs ASA
06

What researchers measure

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

07

Study locations

7 sites
  • 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
08

References and documents

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. PubMed 23246393 ↗
  • 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. PubMed 21798429 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00182104
Lead sponsor
Hamilton Health Sciences Corporation
Collaborators
Heart and Stroke Foundation of Canada
First posted
Sep 16, 2005
Start date
Aug 1998
Completion
Jul 2005
Last update
Apr 20, 2007

Study contacts

Paul Monagle, MD
study chair · Royal Children's Hospital, Parkville, Victoria, Australia
Brian McCrindle, MD
principal investigator · The Hospital for Sick Children
Robin Roberts, MD
principal investigator · McMaster University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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