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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

RecruitingNAAges 18 Years - anyAllMcMaster University
NCT06957366 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • PAUSE Perioperative DOAC Management
  • ASRA Perioperative DOAC Management
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Where

14 sites
Hartford Health Care
Hartford, United States
North Shore University Health
Evanston, United States
Brigham and Woman's Hospital
Boston, United States
Henry Ford Health Care
Detroit, United States
Northwell Health System
New York, United States
Thomas Jefferson University Hospital
Philadelphia, United States
University of Leuven
Leuven, Belgium
Winnipeg Health Sciences Center
Winnipeg, Canada

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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