Status:
TERMINATED
Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Hematoma
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation related to stopping...
Detailed Description
Eligible patients will be equally randomized (1:1) to the Conventional/control arm (bridging anti-coagulation)or to the Experimental arm (continued coumadin). In the Conventional arm there are 2 optio...
Eligibility Criteria
Inclusion
- Any patient undergoing elective device surgery (i.e. de novo device implantation or pulse generator change or lead replacement or pocket revision)
- Patient at moderate or high risk of arterial thrombo-embolic events (ATE) or high risk of venous thrombo-embolic events (VTE) (defined as one or more of following):
- Prosthetic mitral valve replacement
- Caged ball or tilting disc aortic valve prosthesis
- Bileaflet aortic valve prosthesis and one or more of: AF (atrial Fibrillation/Atrial Flutter), prior stroke or TIA, hypertension, diabetes, CHF age \>75
- AFib/Flutter associated with rheumatic valvular heart disease
- Non-rheumatic AFib/Flutter and CHADS2 risk criteria SCORE \> 2
- Non-rheumatic AFib/Flutter and stroke or TIA (within 3 months)
- Persistent/permanent AFib/Flutter on day of acceptance for device surgery AND plan for cardioversion or DFT testing at device implant
- Recent (within 3 months) VTE
- Severe thrombophilia (Protein C or S deficiency or anti-thrombin or anti-phospholipid antibodies or multiple abnormalities)
- Willing to self-inject or have a relative or friend or nurse inject LMWH
Exclusion
- Unable ro unwilling to provide informed consent
- History of noncompliance of medical therapy
- Renal failure with Cr \> 180 umol/l
- Prior Heparin induced thrombocytopenia
- Active device infection
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
984 Patients enrolled
Trial Details
Trial ID
NCT00800137
Start Date
December 1 2008
End Date
March 1 2013
Last Update
August 15 2018
Active Locations (22)
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1
Instituto de Cardiologia - Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, Brazil, 90620 - 000
2
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
3
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
4
Royal Jubilee Hospital
Victoria, British Columbia, Canada, V8R 4R2