Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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 oral anti-coagulant therapy is currently managed by using bridging heparin therapy in patients with moderate to high risk of blood clot formation. There is a substantial risk of bleeding in the pocket where the device is situated (pocket hematoma)related to bridging therapy. The purpose of this study is to compare the current standard of care of bridging with heparin to an experimental strategy of continuing coumadin therapy in higher risk patients undergoing device surgery, with the hypothesis being that the continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to the bridging with heparin group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Warfarin

Criteria

Inclusion Criteria:

1. Any patient undergoing elective device surgery (i.e. de novo device implantation or pulse generator change or lead replacement or pocket revision)

2. 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)

3. Willing to self-inject or have a relative or friend or nurse inject LMWH

Exclusion Criteria:

1. Unable ro unwilling to provide informed consent

2. History of noncompliance of medical therapy

3. Renal failure with Cr > 180 umol/l

4. Prior Heparin induced thrombocytopenia

5. Active device infection