Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISECONTROL)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematoma |
Drug: low molecular weight heparin or unfractionated heparin Drug: Warfarin or coumadin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL) |
- Clinically significant hematoma (defined as hematoma requiring reoperation and/or transfusion and/or unplanned or prolonged hospitalization and/or interruption of LMWH or IV heparin or oral anti-coagulant. [ Time Frame: Device implant until first routine post-op visit ] [ Designated as safety issue: Yes ]
- Components of the primary outcome,composite of all other major peri-operative bleeding events and thrombo-embolic events. [ Time Frame: Device implant to first routine post-op visit ] [ Designated as safety issue: Yes ]
| Enrollment: | 984 |
| Study Start Date: | December 2008 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bridging anti-coagulation
Low Molecular Weight Heparin or IV unfractionated Heparin
|
Drug: low molecular weight heparin or unfractionated heparin
For elective patients with greater than 5 days pre-implant; discontinue oral anti-coagulation (coumadin) 5 days before the procedure. Full therapeutic doses of subcutaneous LMWH 3 days before the procedure. Patients with less than 5 days to implant can be given vitamin K (up to 2 mg) at the investigator discretion and start full therapeutic doses of either subcutaneous LMWH or IV Unfractionated Heparin (choice is at investigator's discretion) when INR is below the upper limit of the prescribed therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6. Last dose given in the morning(ie. > 24 hours)of the day prior to the procedure. Oral anti-coagulation (coumadin) will be resumed on the evening of the procedure. Full dose LMWH or full dose IV heparin will be restarted 24 hours after surgery. |
|
Experimental: Continued oral anti-coagulation
Coumadin
|
Drug: Warfarin or coumadin
Continue on oral anti-coagulant (coumadin). INR on the day of surgery will be < 3.0
|
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 options. Patients with greater than 5 days pre-implant will discontinue oral anti-coagulant (coumadin) 5 days before the procedure,and start full therapeutic doses of subcutaneous low molecular weight heparin (LMWH)3 days before the procedure. Patients with less than 5 days to implant can be given Vitamin K at the investigator's discretion and start full therapeutic doses of either subcutaneous LMWH or IV unfractionated Heparin (choice is at investigator discretion) when the INR is below the therapeutic range for the patient (usually greater than or equal to 2; 2.5 for some valve patients) and surgery to proceed when INR is less than 1.6. Oral anti-coagulant (coumadin) will resume on the evening of the procedure. Full dose LMWH injections or full dose IV heparin will be started 24 hours after surgery.
In the Experimental arm patients will continue on their oral anti-coagulant (coumadin). The INR on the day of surgery will be < 3.0.
ASA will be continued in all patients. Plavix will be continued in patients with drug-eluting stents.
Patients will be monitored for the development of any hematoma or bleeding event during admission. There will be a unblinded team responsible for device implant and follow-up and a blinded team responsible to monitor any bleeding events or hematoma and determine if it meets the primary endpoint criteria for the study. The blinded team will have no knowledge of the treatment arm and will be involved only if the patient develops a hematoma or bleeding event. All hematomas and bleeding events will be followed until resolution.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Brazil | |
| Instituto de Cardiologia - Fundação Universitária de Cardiologia | |
| Porto Alegre, RS, Brazil, 90620 - 000 | |
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Mazankowski Alberta Heart Institute | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| Royal Jubilee Hospital | |
| Victoria, British Columbia, Canada, V8R 4R2 | |
| Canada, Manitoba | |
| Winnipeg Health Sciences Centre | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, New Brunswick | |
| St. John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Hamilton Health Science Center | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| St. Mary's General Hospital | |
| Kitchener, Ontario, Canada, N2M 1B2 | |
| London Health Sciences Center | |
| London, Ontario, Canada, N6A 5A5 | |
| Southlake Regional Health Centre | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Rouge Valley Hospital | |
| Scarborough, Ontario, Canada, M1E 5E9 | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| St. Mike's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Canada, Quebec | |
| Cité-de-la-Santé Hospital | |
| Laval, Quebec, Canada, H7M 3L9 | |
| McGill University Health Center | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Hôpital Sacré-Coeur de Montréal | |
| Montréal, Quebec, Canada, H4J 1C5 | |
| Centre Hospitalier de L'Université de Montréal | |
| Montréal, Quebec, Canada, H2W 1T8 | |
| Hôpital Laval | |
| Québec, Quebec, Canada, G1V 4G5 | |
| Sherbrooke University Hospital Centre CHUS | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Principal Investigator: | David Birnie, MD | University of Ottawa Heart Institute |
More Information
No publications provided
| Responsible Party: | David Birnie, MD, University of Ottawa Heart Institute |
| ClinicalTrials.gov Identifier: | NCT00800137 History of Changes |
| Other Study ID Numbers: | UOHI-02 |
| Study First Received: | November 26, 2008 |
| Last Updated: | April 8, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Ottawa Heart Institute:
|
coumadin device surgery pocket hematoma Pocket hematoma and device surgery |
Additional relevant MeSH terms:
|
Hematoma Hemorrhage Pathologic Processes Calcium heparin Heparin Heparin, Low-Molecular-Weight Dalteparin Warfarin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013