Managing anticoagulants for patients needing high-risk surgery
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
This study is testing a new way to manage blood-thinning medications for patients who need high-risk surgeries to see if it keeps them safer than the current method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 920 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 14 sites (Hartford, Connecticut and 13 other locations) |
| Trial ID | NCT06957366 on ClinicalTrials.gov |
What this trial studies
The PAUSE-2 study evaluates the safety of a new management approach for patients on direct oral anticoagulants (DOACs) who require elective high-bleed-risk surgeries or procedures. It compares the PAUSE management strategy against the ASRA management strategy to determine if PAUSE is as safe as ASRA, with a focus on maintaining low pre-operative DOAC levels. This prospective, open-label, blinded-endpoint non-inferiority randomized controlled trial aims to address the uncertainty surrounding perioperative management of DOACs in high-risk patients. The study is particularly relevant given the increasing use of DOACs and the aging population requiring surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with atrial fibrillation or venous thromboembolism requiring full-dose DOACs and scheduled for high-bleed-risk surgeries or neuraxial anesthesia.
Not a fit: Patients with unusual site thrombosis or those on low-dose DOAC regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer management protocol for patients on DOACs undergoing high-risk surgeries, potentially reducing complications.
How similar studies have performed: Other studies have shown varying degrees of success in managing anticoagulation in surgical settings, but this specific approach is novel and addresses a significant gap in current guidelines.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hartford, Connecticut and 13 other locations
- Hartford Health Care — Hartford, Connecticut, United States (Not_yet_recruiting)
- North Shore University Health — Evanston, Illinois, United States (Not_yet_recruiting)
- Brigham and Woman's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Henry Ford Health Care — Detroit, Michigan, United States (Not_yet_recruiting)
- Northwell Health System — New York, New York, United States (Not_yet_recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- University of Leuven — Leuven, Belgium, Belgium (Not_yet_recruiting)
- Winnipeg Health Sciences Center — Winnipeg, Manitoba, Canada (Not_yet_recruiting)
- St. Joesph's Healthcare — Hamilton, Ontario, Canada (Recruiting)
- Juravinski — Hamilton, Ontario, Canada (Not_yet_recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Not_yet_recruiting)
- L'Hospital Montfort — Ottawa, Ontario, Canada (Not_yet_recruiting)
- Toronto General Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
- University of Thessaly — Larissa, Greece, Greece (Not_yet_recruiting)
Study contacts
- Principal investigator: James Douketis, MD — McMaster University/St. Joseph's Healthcare
- Study coordinator: James Douketis, MD
- Email: jdouket@mcmaster.ca
- Phone: 905-522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.