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

Launched by MCMASTER UNIVERSITY · Apr 25, 2025

Keywords

ClinConnect Summary

The PAUSE-2 study is exploring the safety of two different management strategies for patients who are taking blood thinners called direct oral anticoagulants (DOACs) and need to have a surgery that has a high risk of bleeding. This study is particularly for adults aged 18 and older who have conditions like atrial fibrillation or blood clots in the legs or lungs and are on a full dose of medications like apixaban, dabigatran, edoxaban, or rivaroxaban. If you are having an elective surgery that could involve a lot of bleeding or require special anesthesia techniques, you may be eligible to participate.

Participants in this study will be randomly assigned to receive either the PAUSE management approach or the ASRA management approach. Both methods aim to ensure that most patients have low or undetectable levels of the blood thinner before surgery. This is important because it helps reduce the risk of excessive bleeding during the procedure. The trial is currently recruiting participants, and if you're interested, it's essential to discuss your eligibility with your doctor, who can provide more details on what to expect and how to take part.

Gender

ALL

Eligibility criteria

• 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. 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