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Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure
Sponsor: McMaster University
Summary
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.
Official title: Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure: A Randomized Control Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
920
Start Date
2025-04-01
Completion Date
2027-12-31
Last Updated
2025-05-09
Healthy Volunteers
No
Conditions
Interventions
PAUSE Perioperative DOAC Management
PAUSE management is simple and easy to apply as patients having a high-bleed-risk surgery/neuraxial procedure interrupt DOACs for 2 days before and 2 days after surgery without heparin bridging or DOAC level testing.
ASRA Perioperative DOAC Management
ASRA management is more complex, requiring 72-120 hours DOAC interruption and, in selected patients, pre-operative heparin bridging and DOAC level testing.
Locations (14)
Hartford Health Care
Hartford, Connecticut, United States
North Shore University Health
Evanston, Illinois, United States
Brigham and Woman's Hospital
Boston, Massachusetts, United States
Henry Ford Health Care
Detroit, Michigan, United States
Northwell Health System
New York, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Leuven
Leuven, Belgium, Belgium
Winnipeg Health Sciences Center
Winnipeg, Manitoba, Canada
St. Joesph's Healthcare
Hamilton, Ontario, Canada
Juravinski
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
L'Hospital Montfort
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
University of Thessaly
Larissa, Greece, Greece