Trial record 12 of 29 for:    Open Studies | "Hematoma"

Strategy of Continued Versus Interrupted Dabigatran at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events (BRUISECONTROL2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Ottawa Heart Institute
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01675076
First received: August 27, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine the best strategy to manage Dabigatran at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of Dabigatran will result in a reduced rate of clinically significant hematoma.


Condition Intervention Phase
Hematoma
Drug: Dabigatran
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Dabigatran 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

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Clinically significant hematoma [ Time Frame: 2 weeks post-op or until resolution of hematoma ] [ Designated as safety issue: Yes ]

    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, in response to wound hematoma.


Secondary Outcome Measures:
  • Composite of major peri-operative bleeding events and thrombo-embolic events [ Time Frame: 2 weeks post-op ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 846
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continued Dabigatran
- Patients continue on Dabigatran 110 mg BID throughout
Drug: Dabigatran
Other Names:
  • Pradax
  • Pradaxa
Active Comparator: 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 at least 24 hours after the end of surgery
Drug: Dabigatran
Other Names:
  • Pradax
  • Pradaxa

Detailed Description:

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

All patients in the study will be treated with Dabigatran for at least 5 days prior to surgery. Regardless of the chronic dose, all patients will receive Dabigatran 110 mg BID for 5 days prior to device surgery and for the 5 days following surgery. The peri-operative management of Dabigatran 110 mg BID is randomized to the following:

  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, at least 24 hours after the end of surgery.
  2. Continued Dabigatran

    • patients will continue on Dabigatran 110 mg BID throughout
    • patients will have an aPTT measured at trough (within 2 hours prior to next dose)once within 5 days prior to the surgery. If the aPTT is > 2.5 times the upper limit of normal, the dose of Dabigatran will be held on the morning of surgery.

All patients will have clinical lab testing of serum creatinine, CBC, INR, aPTT, thrombin clotting time (TCT) and Hemoclot test on the day of surgery.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient undergoing device surgery (ie. de novo device implant or pulse generator change or lead replacement or pocket revision)
  • receiving Dabigatran for at least 5 days prior to surgery
  • non-rheumatic AF and/or atrial flutter and CHADS2 score greater than or equal to 2

Exclusion Criteria:

  • unable ot unwilling to provide informed consent
  • history of noncompliance of medical therapy
  • active device infection
  • included in another clinical trial
  • GFR < 30 mL/min
  • contraindication to Dabigatran
  • rheumatic valvular disease with hemodynamically significant valve lesion
  • mechanical heart valve
  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: NCT01675076

Contacts
Contact: Karen MacDonald, RN BPE 613-798-5555 ext 17077 kmacdonald@ottawaheart.ca

Locations
Canada, Alberta
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Principal Investigator: Glen Sumner, MD         
Canada, Ontario
Hamilton Health Sciences General Campus Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Jeff Healey, MD         
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Principal Investigator: Atul Verma, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Karen MacDonald, RN    613-798-5555 ext 17077    kmacdonald@ottawaheart.ca   
Principal Investigator: Pablo Nery, MD         
Canada, Quebec
Hopital Sacre-Coeur Not yet recruiting
Montreal, Quebec, Canada, H4J 1C5
Principal Investigator: Giuliano Becker, MD         
McGill University Health Centre/Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Principal Investigator: Vidal Essebag, MD         
Centre Hospitalier de l'Universite de Montreal (CHUM), Hotel Dieu Recruiting
Montreal, Quebec, Canada, H2W 1T8
Principal Investigator: Benoit Coutu, MD         
Centre Hospitalier Universitaire de Sherbrooke-Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, JiH 5N4
Principal Investigator: Felix Ayala-Paredes, MD         
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec Not yet recruiting
Quebec, Canada, G1V 4G5
Principal Investigator: Francois Philippon, MD         
Sponsors and Collaborators
University of Ottawa Heart Institute
Boehringer Ingelheim
Investigators
Principal Investigator: David Birnie, MD University of Ottawa Heart Institute
Principal Investigator: Vidal Essebag, MD McGill University
Study Chair: Jeff Healey, MD McMaster University
  More Information

No publications provided

Responsible Party: University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01675076     History of Changes
Other Study ID Numbers: UOHI-05
Study First Received: August 27, 2012
Last Updated: August 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:
Hematoma
Dabigatran
Device surgery

Additional relevant MeSH terms:
Hematoma
Thromboembolism
Embolism
Hemorrhage
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014