Trial record 2 of 6 for:    BRIDGE and anticoagulation

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

This study has been terminated.
(At time of pre-specified 2nd interim analysis)
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Birnie, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00800137
First received: November 26, 2008
Last updated: April 8, 2013
Last verified: April 2013
  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)

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800137

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
St. Mike's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Cité-de-la-Santé Hospital
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
Hôpital Laval
Québec, Quebec, Canada, G1V 4G5
Sherbrooke University Hospital Centre CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: David Birnie, MD Ottawa Heart Institute Research Corporation
  More Information

No publications provided by Ottawa Heart Institute Research Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Ottawa Heart Institute Research Corporation:
coumadin
device surgery
pocket hematoma
Pocket hematoma and device surgery

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes
Calcium heparin
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Warfarin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014