Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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