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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation (AF), VTE

In brief

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.

Key facts

Study ID

NCT06957366

Run by

McMaster University

People needed

920

Starts

2025-04-01

Expected to finish

2027-12-31

Last updated by the study team

2025-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Indication for anticoagulation is unusual site thrombosis (e.g. splanchnic, cerebral, sinus, arm)
• Receiving a low-dose DOAC regimen used for secondary VTE prevention (e.g. rivaroxaban 10 mg daily, apixaban 2.5 mg bid) or another low-dose DOAC regimen (e.g. rivaroxaban 2.5 mg bid)
• CrCL<25mL/min (if on apixaban, edoxaban, rivaroxaban) or <30 mL/min (if on dabigatran)
• cognitive impairment or psychiatric illness that precludes reliable contact during follow up.
• Unable or unwilling to provide consent
• Previous participation in PAUSE 2

Where it is running

• St. Joesph's Healthcare — Hamilton, Ontario, Canada (enrolling)
• 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
• Juravinski — Hamilton, Ontario, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• L'Hospital Montfort — Ottawa, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Hartford Health Care — Hartford, Connecticut, United States
• University of Thessaly — Larissa, Greece, Greece

Full record on ClinicalTrials.gov

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