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HematomaPhase 3BRUISECONTROL2NCT01675076

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

A Phase 3 study testing Dabigatran, Rivaroxaban and Apixaban in people with Hematoma, run by Ottawa Heart Institute Research Corporation at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematoma
What is being tested?
Dabigatran, Rivaroxaban and Apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
663 participants
Where
15 sitesin 2 countries
Study dates
Jan 2013to May 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

Canada14 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • University of Alberta-ECAT Group

    Edmonton, Alberta, T5H 3V9

  • Hamilton Health Sciences General Campus

    Hamilton, Ontario, L8L 2X2

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Centre Hospitalier de l'Universite de Montreal (CHUM), Hotel Dieu

    Montreal, Quebec, H2W 1T8

  • McGill University Health Centre/Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Hopital Sacre-Coeur

    Montreal, Quebec, H4J 1C5

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, G1V 4G5

  • Centre Hospitalier Universitaire de Sherbrooke-Hopital Fleurimont

    Sherbrooke, Quebec, JiH 5N4

  • Rouge Valley Health System-Centenary Campus

    Toronto, Ontario, M1E 4B9

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Victoria Cardiac Arrhythmia Trials Inc.

    Victoria, British Columbia, V8T 1Z4

Other trials in Canada

Israel1 site

  • Galilee Medical Center

    Nahariya, 22100

Other trials in Israel

About this study

Official title: 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.

Read the 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.
  1. 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.
  1. 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.

Conditions
Hematoma
Being tested
Dabigatran, Rivaroxaban, Apixaban
Keywords
Hematoma, novel oral anti-coagulant (NOAC), Device surgery
Medical subject headings
Hematoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DabigatranDrug

    Also called Pradaxa

    NOAC

  • RivaroxabanDrug

    Also called Xarelto

    NOAC

  • ApixabanDrug

    Also called Eliquis

    NOAC

Study groups in NCT01675076
Study groupRoleWhat they receive
Continued NOACExperimental- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout
Receives: Drug: Dabigatran; Drug: Rivaroxaban; Drug: Apixaban
Interrupted NOACActive comparatorInterrupted 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
Receives: Drug: Dabigatran; Drug: Rivaroxaban; Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically significant 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
    1. Hematoma resulting in prolongation of hospitalization
    • Defined as extended hospitalization or rehospitalization for > 24 hours, post index surgery, primarily due to hematoma. or
    1. Hematoma requiring interruption of anti-coagulation. - Defined as reversal or intentional withholding of all anticoagulation for > or = 24 hours, in response to wound hematoma.

    Measured: 2 weeks post-op or until resolution of hematoma

Secondary outcomes (1)

  1. Composite of major peri-operative bleeding events and thrombo-embolic events

    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
    1. Thrombo-embolic events defined as:
    • transient ischemic attack
    • stroke
    • deep venous thrombosis
    • pulmonary embolism
    • peripheral embolus to limb
    • peripheral embolus to other major organ
    1. All cause mortality
    2. Cost utilization
    3. Patient quality of life and peri-operative pain, and satisfaction

    Measured: 2 weeks post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionOct 2017
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
663 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01675076
Sponsor's protocol ID
UOHI-05
Acronym
BRUISECONTROL2
Status last verified
Oct 2019
First submitted
27 Aug 2012
Last updated
7 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Birnie DH, Healey JS, Wells GA, Ayala-Paredes F, Coutu B, Sumner GL, Becker G, Verma A, Philippon F, Kalfon E, Eikelboom J, Sandhu RK, Nery PB, Lellouche N, Connolly SJ, Sapp J, Essebag V. Continued vs. interrupted direct oral anticoagulants at the time of device surgery, in patients with moderate to high risk of arterial thrombo-embolic events (BRUISE CONTROL-2). Eur Heart J. 2018 Nov 21;39(44):3973-3979. doi: 10.1093/eurheartj/ehy413.

    PubMed 30462279

  • Essebag V, Healey JS, Joza J, Nery PB, Kalfon E, Leiria TLL, Verma A, Ayala-Paredes F, Coutu B, Sumner GL, Becker G, Philippon F, Eikelboom J, Sandhu RK, Sapp J, Leather R, Yung D, Thibault B, Simpson CS, Ahmad K, Toal S, Sturmer M, Kavanagh K, Crystal E, Wells GA, Krahn AD, Birnie DH. Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2. Circ Arrhythm Electrophysiol. 2019 Oct;12(10):e007545. doi: 10.1161/CIRCEP.119.007545. Epub 2019 Oct 15.

    PubMed 31610718

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dabigatran, Rivaroxaban and Apixaban in people with Hematoma, run by Ottawa Heart Institute Research Corporation at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically significant hematoma (time frame: 2 weeks post-op or until resolution of hematoma). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01675076, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.

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