Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events (BRUISECONTROL2)

October 2, 2019 updated by: Ottawa Heart Institute Research Corporation

A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at the Time of Device Surgery, in Patients With Moderate to High Risk of Arterial Thrombo-embolic Events, Leads to a Reduction in the Incidence of Clinically Significant Hematoma

The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open-label, randomized trial, with 1:1 randomization to either continued NOAC or interrupted NOAC in patients with non-rheumatic atrial fibrillation or atrial flutter and at moderate to high risk of arterial thrombo-embolic events who require device surgery.

All patients in the study will be receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment. The peri-operative management of the NOAC the patient is receiving is randomized to Interrupted NOAC or Continued NOAC.

Interrupted NOAC arm:

  1. Interrupted Dabigatran

    • based on renal function, patients will discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min, and 2 days before surgery if GFR is 30-50 mL/min.
    • Dabigatran will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.

  2. Interrupted Rivaroxaban

    • patients will discontinue Rivaroxaban 1 full day before surgery.
    • Rivaroxaban will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.

  3. Interrupted Apixaban

    • patients will discontinue Apixaban 1 full day before surgery.
    • Apixaban will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.

Continued NOAC arm:

-patients will continue their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout.

All patients will have a baseline clinical lab test of serum creatinine or GRF measured.

Patients will be seen post-op on the day of their surgery for assessment of the surgical site and each day throughout their hospital stay by a blinded member of the research team. A telephone follow-up will be done on day 3-4 post surgery by an unblinded team member. All patients are seen 1-2 weeks post-op at their first routine post-op device clinic visit, for surgical site assessment by the blinded assessor and to complete Quality of Life questionnaires. Patients will be seen for assessment in the case of any bleeding or development of pocket swelling or hematoma. Patients developing a hematoma will be followed until resolution of the hematoma.

Study Type

Interventional

Enrollment (Actual)

663

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Institut universitaire de Cardiologie et de Pneumologie de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
      • Edmonton, Alberta, Canada, T5H 3V9
        • University of Alberta-ECAT Group
    • British Columbia
      • Victoria, British Columbia, Canada, V8T 1Z4
        • Victoria Cardiac Arrhythmia Trials Inc.
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences General Campus
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Hospital
      • Toronto, Ontario, Canada, M1E 4B9
        • Rouge Valley Health System-Centenary Campus
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Sacre-Coeur
      • Montreal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de l'Universite de Montreal (CHUM), Hotel Dieu
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre/Montreal General Hospital
      • Sherbrooke, Quebec, Canada, JiH 5N4
        • Centre Hospitalier Universitaire de Sherbrooke-Hopital Fleurimont
  • Israel
      • Nahariya, Israel, 22100
        • Galilee Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • any patient undergoing device surgery (ie. de novo device implant or pulse generator change or lead replacement or pocket revision)
  • receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment
  • non-rheumatic atrial fibrillation and/or atrial flutter at moderate or high risk of ATE defined as: i) CHA2DS2VASc score greater than or equal to 2 OR ii) CHA2DS2VASc score < 2 with plan for cardioversion or defibrillation threshold testing at time of device surgery

Exclusion Criteria:

  • unable or unwilling to provide informed consent
  • history of noncompliance of medical therapy
  • active device infection
  • eGFR < 30 mL/min
  • contraindication to NOAC
  • rheumatic valvular disease with hemodynamically significant valve lesion
  • mechanical heart valve

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Continued NOAC
- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout
Drug: Dabigatran
NOAC
Other Names:
  • Pradaxa
Drug: Rivaroxaban
NOAC
Other Names:
  • Xarelto
Drug: Apixaban
NOAC
Other Names:
  • Eliquis
ACTIVE_COMPARATOR: Interrupted NOAC

Interrupted Dabigatran:

  • Discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min or discontinue 2 days before surgery if GFR 30-50 mL/min
  • Resume Dabigatran at next regular dose timing >or = 24 hours after the end of surgery

Interrupted Rivaroxaban:

  • Discontinue Rivaroxaban 1 full day before surgery
  • Resume Rivaroxaban at next regular dose timing >or = 24 hours after the end of surgery

Interrupted Apixaban:

  • Discontinue Apixaban 1 full day before surgery
  • Resume Apixaban at next regular dose timing >or = 24 hours after the end of surgery
Drug: Dabigatran
NOAC
Other Names:
  • Pradaxa
Drug: Rivaroxaban
NOAC
Other Names:
  • Xarelto
Drug: Apixaban
NOAC
Other Names:
  • Eliquis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically significant hematoma
Time Frame: 2 weeks post-op or until resolution of hematoma

Defined as:

  1. Hematoma requiring re-operation

    - Defined as a hematoma that continues to expand despite all appropriate non-operative measures, or is producing impending or actual wound breakdown or skin necrosis. Minor hematomas that are evacuated at the time of other re-operation (eg. for lead repositioning) are not considered as a primary outcome.

    or

  2. Hematoma resulting in prolongation of hospitalization

    - Defined as extended hospitalization or rehospitalization for > 24 hours, post index surgery, primarily due to hematoma.

    or

  3. Hematoma requiring interruption of anti-coagulation. - Defined as reversal or intentional withholding of all anticoagulation for > or = 24 hours, in response to wound hematoma.
2 weeks post-op or until resolution of hematoma

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of major peri-operative bleeding events and thrombo-embolic events
Time Frame: 2 weeks post-op
  1. Each of the components of the primary outcome

  2. Composite of all other major peri-operative bleeding events defined as:

    • hemothorax
    • cardiac tamponade
    • significant pericardial effusion

  3. Thrombo-embolic events defined as:

    • transient ischemic attack
    • stroke
    • deep venous thrombosis
    • pulmonary embolism
    • peripheral embolus to limb
    • peripheral embolus to other major organ
  4. All cause mortality
  5. Cost utilization
  6. Patient quality of life and peri-operative pain, and satisfaction
2 weeks post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Bristol-Myers Squibb
Bayer
Boehringer Ingelheim
Heart and Stroke Foundation of Canada

Investigators

  • Principal Investigator: Vidal Essebag, MD, McGill University
  • Study Chair: Jeff Healey, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (ESTIMATE)

August 29, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOHI-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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