Perioperative Anticoagulant Use for Surgery Evaluation Study Part 2 Pilot (PAUSE2rctP)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring anticoagulant, atrial fibrillation, surgery, oral anticoagulant, high risk, blood thinner, DOAC, interruption, discontinue, elective, perioperative
Eligibility Criteria
Inclusion Criteria:
- Adult (age ≥18 years) with AF/flutter who is receiving a DOAC: apixaban 2.5 mg or 5 mg BID; dabigatran 110 mg or 150 mg BID; or rivaroxaban 15 mg or 20 mg QD.
- Undergoing an elective surgery/procedure associated with a high-bleed-risk or any surgery/procedure requiring neuraxial anesthesia (includes regional blocks)
- Patient and their clinician are willing to adhere to DOAC interruption/continuation protocols.
- Patient to resume DOAC after surgery/procedure (i.e., no intent to discontinue DOAC).
Exclusion Criteria:
- Creatinine clearance (CrCl) <30 mL/min (dabigatran, rivaroxaban) and <25 mL/min (apixaban) based on the Cockroft-Gault equation, which is recommended for DOAC dosing.
- Patient taking a DOAC that is infrequently used (i.e., edoxaban, <5% Canadian DOAC market share in 2018) or is not available for clinical use in Canada or Europe (i.e., betrixaban).
- Patient taking a DOAC for a non-AF clinical indication (excluded to maintain study population homogeneity).
- Cognitive impairment or psychiatric illness that precludes collection of follow-up data.
- Inability or unwillingness to provide informed consent.
- Previous participation in PAUSE-2.
Sites / Locations
- Hamilton General HospitalRecruiting
- Juravinski Hospital
- St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Apixaban
Dabigatran
Rivaroxaban
Patients currently taking apixaban that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia.
Patients currently taking dabigatran that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia.
Patients currently taking rivaroxaban that have atrial fibrillation and require an elective high-bleed-risk surgery/neuraxial anesthesia.