Status:
RECRUITING
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
Lead Sponsor:
McMaster University
Conditions:
Atrial Fibrillation (AF)
VTE
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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/p...
Detailed Description
As use of direct oral anticoagulants (DOACs) continues to increase so too will the need to manage such patients who require a surgery/procedure. Perioperative DOAC management is established and guidel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
920 Patients enrolled
Trial Details
Trial ID
NCT06957366
Start Date
April 1 2025
End Date
December 31 2027
Last Update
May 9 2025
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Hartford Health Care
Hartford, Connecticut, United States, 06106
2
North Shore University Health
Evanston, Illinois, United States, 60201
3
Brigham and Woman's Hospital
Boston, Massachusetts, United States, 02115
4
Henry Ford Health Care
Detroit, Michigan, United States, 48202