Managing anticoagulants for patients needing high-risk surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• St. Joesph's Healthcare
  Hamilton, Ontario, Canada Recruiting
• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.