Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial

Hematoma Clinical Trial

— BRUISECONTROL  

Official title:

Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00800137
• Other study ID #: UOHI-02
• Status: Terminated
• Phase: Phase 4
• Start date: December 2008
• Est. completion date: March 2013

Study information

• Verified date: August 2018
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hematoma

Intervention

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.
• Warfarin or coumadin
Continue on oral anti-coagulant (coumadin). INR on the day of surgery will be < 3.0

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

Brazil,  Canada, 

References & Publications (1)

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

Outcome

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

External Links

•   NEJM publication-full study results