Perioperative Anticoagulant Management for Atrial Fibrillation
(PAUSE 2 RCT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it involves managing anticoagulant medications (blood thinners) for surgery. It's best to discuss with the trial team or your doctor.
What data supports the effectiveness of the drug ASRA Perioperative DOAC Management for atrial fibrillation?
The PAUSE study suggests that the perioperative management protocol for direct oral anticoagulants (DOACs) is safe for patients with atrial fibrillation, with low expected risks for major bleeding and arterial thromboembolism. This protocol is designed to be easily applied in clinical practice, providing a standardized yet patient-specific approach.12345
Is the perioperative anticoagulant management for atrial fibrillation generally safe for humans?
The PAUSE study found that the perioperative management of direct oral anticoagulants (DOACs) in patients with atrial fibrillation is generally safe, with low rates of major bleeding and thromboembolic events. The study showed that the standardized management protocol is effective in minimizing risks, with major bleeding rates of 3.02% for apixaban, 2.84% for dabigatran, and 4.16% for rivaroxaban.24678
How does the PAUSE perioperative DOAC management differ from other treatments for atrial fibrillation?
The PAUSE perioperative DOAC management is unique because it provides a standardized yet patient-specific protocol for managing direct oral anticoagulants (DOACs) around the time of surgery, considering factors like the type of DOAC, the patient's kidney function, and the bleeding risk of the surgery. This approach aims to safely balance the risk of bleeding and clotting, unlike traditional methods that may not be as tailored to individual patient needs.12469
What is the purpose of this trial?
PAUSE 2 study is a prospective, open-label, blinded-endpoint non-inferiority RCT of PAUSE vs. ASRA management in DOAC treated high risk patients with AF/VTE who need elective high bleed risk surgery/procedure and/or any procedure involving neuraxial anesthesia. The purpose of the PAUSE 2 study is to show that PAUSE management will be as safe (i.e., non-inferior) as ASRA management, with 95% of patients having low/undetectable pre-operative DOAC levels \<30 ng/mL in each group., at the time of surgery/neuraxial.
Research Team
James Douketis, MD
Principal Investigator
McMaster University/St. Joseph's Healthcare
Joseph Shaw, MD
Principal Investigator
The Ottawa Hospital
Eligibility Criteria
This trial is for patients with atrial fibrillation or deep vein thrombosis who are on DOACs (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) and need elective surgery or a procedure that has a high risk of bleeding. Specific eligibility criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Management
Participants interrupt DOACs for 2 days before surgery without heparin bridging or DOAC level testing (PAUSE) or follow ASRA guidelines with 72-120 hours DOAC interruption and possible heparin bridging and DOAC level testing.
Surgery/Procedure
Participants undergo elective high bleed risk surgery or neuraxial procedure.
Post-operative Management
Participants resume DOACs 2 days after surgery without heparin bridging or DOAC level testing (PAUSE) or follow ASRA guidelines with possible heparin bridging and DOAC level testing.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments for bleeding and thromboembolic events.
Treatment Details
Interventions
- ASRA Perioperative DOAC Management
- PAUSE Perioperative DOAC Management
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor