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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
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Birnie, Ottawa Heart Institute Research Corporation

Tracking Information
First Submitted Date  ICMJE November 26, 2008
First Posted Date  ICMJE December 1, 2008
Last Update Posted Date August 15, 2018
Study Start Date  ICMJE December 2008
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00800137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial
Official Title  ICMJE Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hematoma
Intervention  ICMJE
  • 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.

  • Drug: Warfarin or coumadin
    Continue on oral anti-coagulant (coumadin). INR on the day of surgery will be < 3.0
Study Arms  ICMJE
  • Active Comparator: Bridging anti-coagulation
    Low Molecular Weight Heparin or IV unfractionated Heparin
    Intervention: Drug: low molecular weight heparin or unfractionated heparin
  • Experimental: Continued oral anti-coagulation
    Coumadin
    Intervention: Drug: Warfarin or coumadin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 28, 2008)
984
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800137
Other Study ID Numbers  ICMJE UOHI-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Birnie, Ottawa Heart Institute Research Corporation
Study Sponsor  ICMJE Ottawa Heart Institute Research Corporation
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: David Birnie, MD Ottawa Heart Institute Research Corporation
PRS Account Ottawa Heart Institute Research Corporation
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP