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

Hematoma Clinical Trial

— BRUISECONTROL2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675076
• Other study ID #: UOHI-05
• Status: Completed
• Phase: Phase 3
• Start date: January 2013
• Est. completion date: May 2018

Study information

• Verified date: October 2019
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 significant hematoma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 663
• Est. completion date: May 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematoma

Intervention

Drug:
• Dabigatran
NOAC
• Rivaroxaban
NOAC
• Apixaban
NOAC

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta-ECAT Group	Edmonton	Alberta
Canada	Hamilton Health Sciences General Campus	Hamilton	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM), Hotel Dieu	Montreal	Quebec
Canada	Hopital Sacre-Coeur	Montreal	Quebec
Canada	McGill University Health Centre/Montreal General Hospital	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke-Hopital Fleurimont	Sherbrooke	Quebec
Canada	Humber River Hospital	Toronto	Ontario
Canada	Rouge Valley Health System-Centenary Campus	Toronto	Ontario
Canada	Victoria Cardiac Arrhythmia Trials Inc.	Victoria	British Columbia
Israel	Galilee Medical Center	Nahariya

Sponsors (5)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Heart and Stroke Foundation of Canada

Countries where clinical trial is conducted

Canada,  Israel, 

References & Publications (1)

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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant hematoma	Defined as: 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; Hematoma resulting in prolongation of hospitalization; - Defined as extended hospitalization or rehospitalization for > 24 hours, post index surgery, primarily due to hematoma.; or; 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	Composite of major peri-operative bleeding events and thrombo-embolic events	Each of the components of the primary outcome; Composite of all other major peri-operative bleeding events defined as: hemothorax; cardiac tamponade; significant pericardial effusion; Thrombo-embolic events defined as: transient ischemic attack; stroke; deep venous thrombosis; pulmonary embolism; peripheral embolus to limb; peripheral embolus to other major organ; All cause mortality; Cost utilization; Patient quality of life and peri-operative pain, and satisfaction	2 weeks post-op