Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT06844227

Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual)

Led by McMaster University · Updated on 2025-03-10

1780

Participants Needed

10

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of the PAUSE-Virtual Study is to show that by changing pre-surgery visits with patients taking a blood thinner (direct oral anticoagulant (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) when the participant requires elective surgery, using a standard, in-person proven approach, to a virtual visit, either telephone or video conference, is as safe. Patients who are receiving a blood thinner for the medical condition known as atrial fibrillation (AF) and require an elective surgery/procedure, is common. These patients have to stop taking their blood thinner for a certain time before the procedure to reduce serious complications of stroke or bleeding. For doctors who help manage these patients before a procedure, appointments have been traditionally done in-person. Patients receive instructions about when to stop and restart their blood thinners and taught how to self-administrator a short acting blood thinner (heparin) if needed. The COVID pandemic changed the way these appointments were done, making it important to contact these patients without them having to come to the hospital for an in person visit. Virtual patient care, by telephone or video conference, to communicate to patients about when to start and restart their blood thinner was necessary. This study wants to show that this virtual method of instruction, using a standardized plan of managing patient care, is easy, acceptable to patients and as safe when compared to an in-person meeting. Such instruction would also be cost-efficient standard post-pandemic. Prior work has shown that both a standard care of patients who are receiving blood thinners and a point-of-care decision "app", available through Thrombosis Canada (www.thrombosiscanada.ca) website, have been trusted during this virtual visit successfully. The investigator will show, by following up at 30 days, that this standardized management plan is safe and can be done virtually, with a low risk of stroke and major bleeding.

CONDITIONS

Official Title

Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual)

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older with atrial fibrillation or atrial flutter requiring anticoagulation
  • Receiving warfarin with target INR 2.0-3.0 or a direct oral anticoagulant (apixaban, dabigatran, edoxaban, rivaroxaban) at specified doses
  • Require an elective, planned, non-urgent surgery or invasive medical or surgical procedure
Not Eligible

You will not qualify if you...

  • Anticoagulation indication other than atrial fibrillation or flutter (e.g., mechanical heart valve, venous thromboembolism, other)
  • Use of non-standard anticoagulant regimens (e.g., warfarin INR 3-4, rivaroxaban 2.5 mg twice daily)
  • For direct oral anticoagulant users: creatinine clearance less than 25 mL/min
  • Cognitive impairment or psychiatric illness preventing reliable follow-up contact
  • Unable or unwilling to provide consent for virtual care
  • Previous participation in this study for an elective surgery or procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Endeavor Health - Northshore

Evanston, Illinois, United States, 60201

Actively Recruiting

2

Henry Ford

Detroit, Michigan, United States, 482032

Actively Recruiting

3

Northwell Health

Great Neck, New York, United States, 11021

Actively Recruiting

4

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

5

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada, B3H 3A7

Actively Recruiting

6

Hamilton General Hospital

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

7

St. Joesph's Healthcare

Hamilton, Ontario, Canada, L8N 4A6

Actively Recruiting

8

Juravinski

Hamilton, Ontario, Canada, L8V 1C3

Actively Recruiting

9

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

10

Larissa University Hospital

Larissa, Larisa, Greece, 413 34

Actively Recruiting

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Research Team

J

James D Douketis, MD

CONTACT

M

Melanie St John

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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