Perioperative Anticoagulant Use for Surgery Evaluation Study
NCT ID: NCT02228798
Last Updated: 2019-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3135 participants
OBSERVATIONAL
2014-08-01
2018-08-31
Brief Summary
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Detailed Description
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The secondary aim of the PAUSE Study is to determine the effect of the pre-operative DOAC interruption protocol on the level of residual anticoagulation, when measured by 'everyday' coagulation tests that are not DOAC-specific (e.g., activated partial thromboplastin time \[aPTT\]) and 'specialized' coagulation tests that are DOAC-specific (dilute thrombin time \[TT\] - HemoclotTM, and anti-factor Xa assays).
Approximately 3,300 patients from 15 to 25 centres over a 3.5 year period will be recruited across Canada for the PAUSE Study.
Patients with Atrial Fibrillation and are currently taking dabigatran, rivaroxaban and apixaban (DOACs) and require elective surgery/procedure will follow a standardized management perioperative protocol for discontinuation of their DOAC prior to surgery. Patients will be discontinuing the DOAC they are currently receiving from 1 to 4 days prior to surgery or procedure, depending on bleed risk, type of DOAC, and creatinine clearance rate.
A blood sample will be taken on the day of the surgery or procedure for measurement of laboratory outcomes (residual level of anticoagulant on day of surgery).
Patients will be followed up weekly up to a month for primary outcome assessments.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rivaroxaban
Patients currently taking rivaroxaban that have atrial fibrillation and require surgery or a procedure.
No interventions assigned to this group
Dabigatran
Patients currently taking dabigatran that have atrial fibrillation and require surgery or a procedure.
No interventions assigned to this group
Apixaban
Patients currently taking apixaban that have atrial fibrillation and require surgery or a procedure.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Receiving a DOAC (dabigatran or rivaroxaban or apixaban) for Atrial Fibrillation
3. Ability to assess patient at lease one day prior to DOAC discontinuation
Exclusion Criteria
2. Cognitive impairment or psychiatric illness that precludes collection of followup data
3. Inability or unwillingness to provide informed consent
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Heart and Stroke Foundation of Canada
OTHER
McMaster University
OTHER
Responsible Party
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James Douketis
Dr. James Douketis-Principal Investigator
Principal Investigators
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James Douketis, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University/St. Joseph's Healthcare
Locations
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Department of Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA
Aurora, Colorado, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
Department of Cardiovascular Sciences, University of Leuven
Leuven, , Belgium
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
QEII Hospital
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Juravinski Hospital
Hamilton, Ontario, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
North York General
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
University of Manitoba
Winnipeg, Ontario, Canada
Maisonneuve-Rosemont
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Montreal Jewish General Hospital
Montreal, Quebec, Canada
St. Mary's Hospital
Montreal, Quebec, Canada
Department of Anesthesiology, University of Thessaly
Larissa, , Greece
Department of Vascular Medicine, Amsterdam Cardiovascular Sciences
Amsterdam, , Netherlands
Countries
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References
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Shaw JR, Li N, Vanassche T, Coppens M, Spyropoulos AC, Syed S, Radwi M, Duncan J, Schulman S, Douketis JD. Predictors of preprocedural direct oral anticoagulant levels in patients having an elective surgery or procedure. Blood Adv. 2020 Aug 11;4(15):3520-3527. doi: 10.1182/bloodadvances.2020002335.
Other Identifiers
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CIHR313156 HSFG-14-0006163
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CIHR-PAUSE-2014
Identifier Type: -
Identifier Source: org_study_id
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