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PAUSE-2 Study for DOAC Management Before Surgery

This study, called PAUSE-2, is for people taking certain blood thinners (dabigatran, rivaroxaban, apixaban, or edoxaban) for conditions like atrial fibrillation (an irregular heartbeat) or VTE (blood clots in veins) who need surgery with a high risk of bleeding or a spinal/epidural procedure. It compares two ways to manage these blood thinners before and after surgery: the PAUSE method and the ASRA method. The PAUSE method involves stopping your blood thinner for 2 days before and 2 days after surgery, without using other blood thinners or special tests. The ASRA method is more involved, requiring 3 to 5 days of stopping your blood thinner, and sometimes includes other blood thinners or tests. The study aims to see if the PAUSE method is just as safe and effective as the ASRA method, specifically by checking if your blood thinner levels are low enough before surgery. About 920 people are planned to join.

Study design
This is an open-label, blinded-endpoint randomized controlled trial comparing two different ways to manage blood thinners before surgery. It plans to enroll 920 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures blood thinner levels at Day 1 (before surgery).

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NCT06957366

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

Recruiting
NAAges 18+InterventionalTreatment
McMaster University
~920 participants
Updated 2025-05-09 on ClinicalTrials.gov
What's tested:PAUSE Perioperative DOAC ManagementASRA Perioperative DOAC Management

At a glance

Recruiting sites
1 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients randomized to each study arm with a residual pre-operative DOAC level < 30 ng/mL
Measured over Day 1

Conditions

Atrial Fibrillation (AF)
VTE

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Atrial FibrillationVenous Thromboembolism

Where it's being run

14 sites across 10 states
Ontario5
Connecticut1
Illinois1
Massachusetts1
Michigan1
New York1
Pennsylvania1
Belgium1

Study leadership

  • James Douketis, MD · PRINCIPAL_INVESTIGATOR · McMaster University/St. Joseph's Healthcare
  • Joseph Shaw, MD · PRINCIPAL_INVESTIGATOR · The Ottawa Hospital

Who to contact

James Douketis, MD
[email protected]
905-522-1155 · ext. 36178
Email the study team

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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

What this trial measures

  • Proportion of patients randomized to each study arm with a residual pre-operative DOAC level < 30 ng/mLDay 1

    The primary outcome in PAUSE-2 will be the proportion of patients with a residual pre-operative DOAC level \< 30 ng/mL. Pre-operative DOAC levels will be measured using calibrated anti-Xa assays for direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and will be measured using a dilute thrombin time assay for dabigatran-treated patients.