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 (NCT06957366)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Hartford Health Care — Hartford, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
- PAUSE Perioperative DOAC Management (OTHER)
- ASRA Perioperative DOAC Management (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Hartford Health Care — Hartford, Connecticut
- North Shore University Health — Evanston, Illinois
- Brigham and Woman's Hospital — Boston, Massachusetts
- Henry Ford Health Care — Detroit, Michigan
- Northwell Health System — New York, New York
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- University of Leuven — Leuven, Belgium
- Winnipeg Health Sciences Center — Winnipeg, Manitoba
- St. Joesph's Healthcare — Hamilton, Ontario
- Juravinski — Hamilton, Ontario
- The Ottawa Hospital — Ottawa, Ontario
- L'Hospital Montfort — Ottawa, Ontario
- Toronto General Hospital — Toronto, Ontario
- University of Thessaly — Larissa, Greece
📞 Contact the Study Coordinator
Phone: (905) 522-1155
Email: jdouket@mcmaster.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.