RecruitingNAINTERVENTIONAL

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

The PAUSE 2 study investigates the best way to handle 'direct oral anticoagulants' (DOACs) – common blood thinners like apixaban, dabigatran, edoxaban, or rivaroxaban – for patients who need surgery where there's a higher risk of bleeding, or certain types of anaesthetics. It compares two different strategies, called PAUSE and ASRA management, to see which is safer and more effective. The main goal is to ensure that the blood thinner's effect is low enough before surgery to reduce bleeding risks, without increasing the risk of blood clots. This is important for patients with conditions like atrial fibrillation or those who have had blood clots.

At a glance

Status

Recruiting

Phase

Sponsor

McMaster University

Enrolment target

920

Start

01 Apr 2025

Estimated completion

31 Dec 2027

Atrial Fibrillation (AF)VTE

What is this study about?

Many patients take blood-thinning medicines, called DOACs, to prevent serious problems like strokes, especially if they have an irregular heartbeat (atrial fibrillation) or have had blood clots in the past (VTE). Sometimes, these patients need surgery, and doctors need to carefully manage their blood thinners to prevent too much bleeding during the operation. However, stopping them too early could increase the risk of a blood clot forming.

This study, called PAUSE-2, focuses on patients who are taking these DOACs and need a surgery or procedure that carries a higher risk of bleeding, or who will be having specific types of pain relief like a spinal or epidural injection. There isn't a clear, widely agreed-upon best way to manage DOACs in these specific high-risk situations, and current guidelines often don't have strong recommendations due to a lack of detailed research.

The PAUSE-2 study aims to compare two different strategies for managing these blood thinners. One strategy is called 'PAUSE management' and the other is 'ASRA management'. The study wants to find out if the PAUSE approach is just as safe and effective as the ASRA approach, particularly in ensuring that the level of blood thinners in a patient's body is low enough before surgery, reducing the chance of excessive bleeding.

Key takeaways

Compares two ways to stop/restart blood thinners (DOACs) before high-risk surgery.
Aims to find the safest method for patients with atrial fibrillation or past blood clots.
Important for reducing bleeding risk during surgery while preventing new blood clots.
Participation involves following specific medication instructions and follow-up checks.
Helps improve future care for many patients requiring surgery while on blood thinners.

Who may be eligible?

To be considered for this study, you must be 18 years or older and currently taking a full dose of a specific blood thinner (apixaban, dabigatran, edoxaban, or rivaroxaban) for conditions like atrial fibrillation or a past blood clot. You also need to be scheduled for a surgery or procedure that has a higher risk of bleeding, or a procedure involving spinal or epidural pain relief.

You would not be able to join if you're taking a lower dose of these blood thinners, if your blood thinner is for a less common type of blood clot (like in the gut or brain), or if you have severe kidney problems. Also, if a doctor thinks you might have difficulty understanding or remembering study instructions, or if you've already been part of this specific PAUSE 2 study before, you wouldn't be eligible. It's important to be willing and able to give your informed consent to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you taking a full dose of Apixaban, Dabigatran, Edoxaban, or Rivaroxaban?
Is your medication for atrial fibrillation or a past blood clot (DVT/PE)?
Are you having a surgery or procedure with a higher risk of bleeding, or a spinal/epidural?
Do you feel you can understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you join the PAUSE-2 study, you would be assigned to one of two different plans for managing your blood thinner medication before, during, and right after your high-risk surgery or procedure. This would involve specific instructions on when to stop and restart your medication. The study will monitor your blood thinner levels before your procedure to make sure they are very low. You will have regular checks and follow-up after your surgery to monitor for any bleeding or blood clots. The total duration of your participation in the study, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study could help doctors understand the safest way to manage blood thinners for patients like you, potentially improving care for many people in the future. While the study compares two established management strategies, there's always a small risk associated with managing blood thinners around surgery, including potential bleeding or, less commonly, blood clots. The study aims to minimize these risks by closely monitoring you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (14)

Hartford Health Care
Verified postcode
Hartford, United States· Not yet recruiting
North Shore University Health
Verified postcode
Evanston, United States· Not yet recruiting
Brigham and Woman's Hospital
Verified postcode
Boston, United States· Not yet recruiting
Henry Ford Health Care
Verified postcode
Detroit, United States· Not yet recruiting
Northwell Health System
Verified postcode
New York, United States· Not yet recruiting
Thomas Jefferson University Hospital
Verified postcode
Philadelphia, United States· Not yet recruiting
University of Leuven
Verified postcode
Leuven, Belgium· Not yet recruiting
Winnipeg Health Sciences Center
Verified postcode
Winnipeg, Canada· Not yet recruiting
St. Joesph's Healthcare
Verified postcode
Hamilton, Canada· Recruiting
Juravinski
Verified postcode
Hamilton, Canada· Not yet recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Not yet recruiting
L'Hospital Montfort
Verified postcode
Ottawa, Canada· Not yet recruiting

Common questions

What is a 'DOAC'?

DOAC stands for Direct Oral Anticoagulant. These are commonly prescribed medicines that thin your blood to prevent clots, like Apixaban, Rivaroxaban, Dabigatran, and Edoxaban.

Why is this study needed?

Doctors need clearer guidelines on how to best manage blood thinners for people having surgery with a higher risk of bleeding, to keep them safe from both bleeding and clots.

What conditions require blood thinners?

Common conditions include atrial fibrillation (an irregular heartbeat) and having had a blood clot in your leg (DVT) or lung (pulmonary embolism) in the past.

Will I be told what to do with my medication?

Yes, if you join, you will receive clear, specific instructions on how to manage your blood thinner medication around your surgery or procedure.

What happens if I change my mind?

You are completely free to leave the study at any point without it affecting your usual medical care or relationship with your doctor.

How to find out more

James Douketis, MD

jdouket@mcmaster.ca 905-522-1155 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.