Hematoma Clinical Trial
— BRUISECONTROLOfficial title:
Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)
NCT number | NCT00800137 |
Other study ID # | UOHI-02 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2008 |
Est. completion date | March 2013 |
Verified date | August 2018 |
Source | Ottawa Heart Institute Research Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 984 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto de Cardiologia - Fundação Universitária de Cardiologia | Porto Alegre | RS |
Canada | University of Calgary | Calgary | Alberta |
Canada | Mazankowski Alberta Heart Institute | Edmonton | Alberta |
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Canada | Hamilton Health Science Center | Hamilton | Ontario |
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | St. Mary's General Hospital | Kitchener | Ontario |
Canada | Cité-de-la-Santé Hospital | Laval | Quebec |
Canada | London Health Sciences Center | London | Ontario |
Canada | McGill University Health Center | Montreal | Quebec |
Canada | Centre Hospitalier de L'Université de Montréal | Montréal | Quebec |
Canada | Hôpital Sacré-Coeur de Montréal | Montréal | Quebec |
Canada | Southlake Regional Health Centre | Newmarket | Ontario |
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Canada | Hôpital Laval | Québec | Quebec |
Canada | St. John Regional Hospital | Saint John | New Brunswick |
Canada | Rouge Valley Hospital | Scarborough | Ontario |
Canada | Sherbrooke University Hospital Centre CHUS | Sherbrooke | Quebec |
Canada | St. Mike's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Royal Jubilee Hospital | Victoria | British Columbia |
Canada | Winnipeg Health Sciences Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation | Canadian Institutes of Health Research (CIHR) |
Brazil, Canada,
Birnie DH, Healey JS, Wells GA, Verma A, Tang AS, Krahn AD, Simpson CS, Ayala-Paredes F, Coutu B, Leiria TL, Essebag V; BRUISE CONTROL Investigators. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013 May 30;368 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Device implant until first routine post-op visit | ||
Secondary | Components of the primary outcome,composite of all other major peri-operative bleeding events and thrombo-embolic events. | Device implant to first routine post-op visit |
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