Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receivi
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 man
| Condition(s) | Atrial Fibrillation (AF), VTE |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 participate | 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. riva |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | McMaster University |
| Locations | Hartford, Connecticut, United States; Evanston, Illinois, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States (+8 more sites) |
| Start date | 2025-04-01 |
| NCT ID | NCT06957366 |
| Official listing | https://clinicaltrials.gov/study/NCT06957366 |