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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00182104




Registration number
NCT00182104
Ethics application status
Date submitted
9/09/2005
Date registered
16/09/2005
Date last updated
20/04/2007

Titles & IDs
Public title
International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Scientific title
An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Secondary ID [1] 0 0
Hearth and Stroke grant 1998
Secondary ID [2] 0 0
CTMG-1998-Fontan
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Defect 0 0
Triscupid Atresia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Identify subpopulation of Fontan pts at high risk for TEs
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Determine high risk period for TEs in first 2 yrs post Fontan
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
1. Patient is scheduled to have a Fontan or modified Fontan procedure
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Hamilton Health Sciences Corporation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Heart and Stroke Foundation of Canada
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
Trial website
https://clinicaltrials.gov/study/NCT00182104
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Paul Monagle, MD
Address 0 0
Royal Children's Hospital, Parkville, Victoria, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00182104