Pausing blood thinners before surgery in people with atrial fibrillation or clots
Compares two ways to stop blood thinners before surgery in adults.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Leuven, BelgiumSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atrial fibrillation or a blood clot in the leg or lung, who take a full-dose blood thinner by mouth and need planned surgery with high bleeding risk or spinal-type anesthesia.
- Age
- 18 years or older
- Sex
- All
- Disease stage
- Atrial fibrillation or flutter, or a blood clot in the leg or lung (VTE), needing a full (therapeutic) dose of a blood thinner by mouth. High-risk patients having planned surgery with high bleeding risk, or planned surgery with epidural, spinal or regional anesthesia or a deep nerve root block.
- Earlier treatment
- Must take a full-dose direct oral anticoagulant: apixaban 2.5 mg or 5 mg twice daily; dabigatran 110 mg or 150 mg twice daily; edoxaban 30 mg or 60 mg daily; or rivaroxaban 15 mg or 20 mg daily.
Main reasons for not taking part
- Blood clot in an unusual place (for example abdomen, brain, sinus or arm)
- Low-dose blood thinner (for example rivaroxaban 10 mg daily, apixaban 2.5 mg twice daily for clot prevention, or rivaroxaban 2.5 mg twice daily)
- Kidney function too low: CrCL below 25 mL/min (apixaban, edoxaban, rivaroxaban) or below 30 mL/min (dabigatran)
- Memory problems or mental illness that prevent reliable contact during follow-up
- Unable or unwilling to give consent, or took part in PAUSE 2 before
Read by machine on 9 November 2026.
Where in Belgium
- University of LeuvenLeuven, BelgiumContact: Thomas Vanassche, MD (principal investigator)Not yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- McMaster University
- Trial code
- NCT06957366
- Record updated
- 9 May 2025
- Original description
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.Read full original descriptionShow less
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: A Randomized Control Trial
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.
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: 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); Previous participation in PAUSE 2; Indication for anticoagulation is unusual site thrombosis (e.g. splanchnic, cerebral, sinus, arm); cognitive impairment or psychiatric illness that precludes reliable contact during follow up; CrCL<25mL/min (if on apixaban, edoxaban, rivaroxaban) or <30 mL/min (if on dabigatran); Unable or unwilling to provide consent.