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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults, age 18 years of age or greater, with AF/flutter (permanent, persistent or paroxysmal) or VTE (leg deep vein thrombosis or pulmonary embolism) that require a full (therapeutic)-dose DOAC regimen, appropriate for age and renal function, comprising one of (a) apixaban 2.5 mg or 5 mg bid; (b) dabigatran 110 mg or 150 mg bid; (c) edoxaban 30 mg or 60 mg daily; or (d) rivaroxaban 15 mg or 20 mg daily
• High-risk patient having an elective high-bleed-risk surgery or any elective surgery with neuraxial anesthesia (epidural, spinal, regional) or any deep nerve root block.
Locations
United States
Connecticut
Hartford Health Care
NOT_YET_RECRUITING
Hartford
Illinois
North Shore University Health
NOT_YET_RECRUITING
Evanston
Massachusetts
Brigham and Woman's Hospital
NOT_YET_RECRUITING
Boston
Michigan
Henry Ford Health Care
NOT_YET_RECRUITING
Detroit
New York
Northwell Health System
NOT_YET_RECRUITING
New York
Pennsylvania
Thomas Jefferson University Hospital
NOT_YET_RECRUITING
Philadelphia
Other Locations
Belgium
University of Leuven
NOT_YET_RECRUITING
Leuven
Canada
Juravinski
NOT_YET_RECRUITING
Hamilton
St. Joesph's Healthcare
RECRUITING
Hamilton
L'Hospital Montfort
NOT_YET_RECRUITING
Ottawa
The Ottawa Hospital
NOT_YET_RECRUITING
Ottawa
Toronto General Hospital
NOT_YET_RECRUITING
Toronto
Winnipeg Health Sciences Center
NOT_YET_RECRUITING
Winnipeg
Greece
University of Thessaly
NOT_YET_RECRUITING
Larissa
Contact Information
Primary
James Douketis, MD
jdouket@mcmaster.ca
905-522-1155
Backup
Melanie St John
stjohm1@mcmaster.ca
Time Frame
Start Date:2025-04-01
Estimated Completion Date:2027-12-31
Participants
Target number of participants:920
Treatments
Active_comparator: Apixaban
Patients currently taking Apixaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
Active_comparator: Dabigatran
Patients currently taking Dabigatran that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
Active_comparator: Rivaroxaban
Patients currently taking Rivaroxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.
Active_comparator: Edoxaban
Patients currently taking Edoxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.