Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISECONTROL)
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|ClinicalTrials.gov Identifier: NCT00800137|
Recruitment Status : Terminated (At time of pre-specified 2nd interim analysis)
First Posted : December 1, 2008
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematoma||Drug: low molecular weight heparin or unfractionated heparin Drug: Warfarin or coumadin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||984 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800137
|Principal Investigator:||David Birnie, MD||Ottawa Heart Institute Research Corporation|