Status:
COMPLETED
Perioperative Anticoagulant Use for Surgery Evaluation Study
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, is to establish a safe, standardized protocol for the perioperative management of patients with atrial fibrillation...
Detailed Description
The primary aim is to demonstrate that a standardized but patient-focused protocol for the perioperative management of each DOAC is safe, with acceptably low rates of perioperative major bleeding (MB)...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Receiving a DOAC (dabigatran or rivaroxaban or apixaban) for Atrial Fibrillation
- Ability to assess patient at lease one day prior to DOAC discontinuation
Exclusion
- CrCl less than 30 mL per min for dabigatran- and rivaroxaban-treated patients ( less than 25 mL per min for apixaban-treated patients) as estimated by Cockroft-Gault formula
- Cognitive impairment or psychiatric illness that precludes collection of followup data
- Inability or unwillingness to provide informed consent
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
3135 Patients enrolled
Trial Details
Trial ID
NCT02228798
Start Date
August 1 2014
End Date
August 31 2018
Last Update
June 28 2019
Active Locations (21)
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1
Department of Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA
Aurora, Colorado, United States
2
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
Department of Cardiovascular Sciences, University of Leuven
Leuven, Belgium