RecruitingNot ApplicableNCT06957366

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

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


Sponsor

McMaster University

Enrollment

920 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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/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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a simple, standardized plan for safely stopping and restarting blood thinners (called DOACs — direct oral anticoagulants) around the time of surgery. People who take these medications for atrial fibrillation or blood clots face a tricky balance: stopping too early increases clot risk, while stopping too late increases bleeding risk. This study tests a standardized timing protocol. **You may be eligible if...** - You are 18 or older - You take a DOAC (apixaban, dabigatran, rivaroxaban, or edoxaban) for atrial fibrillation, atrial flutter, or a prior blood clot (DVT or pulmonary embolism) - You are scheduled for an elective (non-emergency) surgery or procedure that carries a high bleeding risk, or any surgery requiring spinal or epidural anesthesia **You may NOT be eligible if...** - You take blood thinners for an unusual clot location (such as brain, gut, or arm veins) - You are on a low-dose DOAC regimen used specifically for preventing recurrent blood clots - Your surgery is urgent or emergent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPAUSE Perioperative DOAC Management

PAUSE management is simple and easy to apply as patients having a high-bleed-risk surgery/neuraxial procedure interrupt DOACs for 2 days before and 2 days after surgery without heparin bridging or DOAC level testing.

OTHERASRA Perioperative DOAC Management

ASRA management is more complex, requiring 72-120 hours DOAC interruption and, in selected patients, pre-operative heparin bridging and DOAC level testing.


Locations(14)

Hartford Health Care

Hartford, Connecticut, United States

North Shore University Health

Evanston, Illinois, United States

Brigham and Woman's Hospital

Boston, Massachusetts, United States

Henry Ford Health Care

Detroit, Michigan, United States

Northwell Health System

New York, New York, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Leuven

Leuven, Belgium, Belgium

Winnipeg Health Sciences Center

Winnipeg, Manitoba, Canada

St. Joesph's Healthcare

Hamilton, Ontario, Canada

Juravinski

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

L'Hospital Montfort

Ottawa, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

University of Thessaly

Larissa, Greece, Greece

View Full Details on ClinicalTrials.gov

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NCT06957366


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