Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISECONTROL)
|Hematoma||Drug: low molecular weight heparin or unfractionated heparin Drug: Warfarin or coumadin||Phase 4|
|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 ]
- 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 ]
|Study Start Date:||December 2008|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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
Drug: Warfarin or coumadin
Continue on oral anti-coagulant (coumadin). INR on the day of surgery will be < 3.0
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800137
|Instituto de Cardiologia - Fundação Universitária de Cardiologia|
|Porto Alegre, RS, Brazil, 90620 - 000|
|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|
|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|
|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|
|Laval, Quebec, Canada, H7M 3L9|
|McGill University Health Center|
|Montreal, Quebec, Canada, H3G 1A4|
|Centre Hospitalier de L'Université de Montréal|
|Montréal, Quebec, Canada, H2W 1T8|
|Hôpital Sacré-Coeur de Montréal|
|Montréal, Quebec, Canada, H4J 1C5|
|Québec, Quebec, Canada, G1V 4G5|
|Sherbrooke University Hospital Centre CHUS|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||David Birnie, MD||Ottawa Heart Institute Research Corporation|