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 · NCT06957366 · Interventional (participants receive a specific treatment) · Lead sponsor: McMaster University
View the official record on ClinicalTrials.gov →Interventions studied
ASRA Perioperative DOAC ManagementPAUSE Perioperative DOAC Management
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
14 locations listed across 6 US states.
- 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
- University of Thessaly - Larissa, Greece, Greece
- 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