Clinical trial NCT00182104: International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Official title: An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Defect
Triscupid Atresia
Keywords: Fontan procedure
Anticoagulation
Thrombosis
Thromboembolism
Prevention
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2005-09-16
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
Secondary outcomes:
measure: Identify subpopulation of Fontan pts at high risk for TEs
measure: Determine high risk period for TEs in first 2 yrs post Fontan
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta HSC
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Sick Children's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Ste-Justine
state: Quebec
Study officials:
affiliation: Royal Children's Hospital, Parkville, Victoria, Australia
name: Paul Monagle, MD
role: STUDY_CHAIR
affiliation: The Hospital for Sick Children
name: Brian McCrindle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Robin Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.