Actively 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
Led by McMaster University · Updated on 2025-05-09
920
Participants Needed
14
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with atrial fibrillation/flutter or venous thromboembolism requiring full-dose DOAC treatment
- Taking one of these DOACs at approved doses: apixaban, dabigatran, edoxaban, or rivaroxaban
- Scheduled for elective high-bleed-risk surgery or any elective surgery with neuraxial anesthesia or deep nerve root block
You will not qualify if you...
- Anticoagulation for unusual site thrombosis such as splanchnic, cerebral, sinus, or arm thrombosis
- Using low-dose DOAC regimens for secondary VTE prevention or other low-dose DOACs
- Severe kidney impairment with creatinine clearance below 25 mL/min (30 mL/min if on dabigatran)
- Cognitive or psychiatric conditions that prevent reliable follow-up contact
- Unable or unwilling to provide consent
- Previous participation in the PAUSE 2 study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Hartford Health Care
Hartford, Connecticut, United States, 06106
Not Yet Recruiting
2
North Shore University Health
Evanston, Illinois, United States, 60201
Not Yet Recruiting
3
Brigham and Woman's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
4
Henry Ford Health Care
Detroit, Michigan, United States, 48202
Not Yet Recruiting
5
Northwell Health System
New York, New York, United States, 10305
Not Yet Recruiting
6
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
7
University of Leuven
Leuven, Belgium, Belgium
Not Yet Recruiting
8
Winnipeg Health Sciences Center
Winnipeg, Manitoba, Canada
Not Yet Recruiting
9
St. Joesph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
10
Juravinski
Hamilton, Ontario, Canada
Not Yet Recruiting
11
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Not Yet Recruiting
12
L'Hospital Montfort
Ottawa, Ontario, Canada
Not Yet Recruiting
13
Toronto General Hospital
Toronto, Ontario, Canada
Not Yet Recruiting
14
University of Thessaly
Larissa, Greece, Greece
Not Yet Recruiting
Research Team
J
James Douketis, MD
CONTACT
M
Melanie St John
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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