RecruitingNCT06844227

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

Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual), a Simple Perioperative Anticoagulant Management Approach, Replacing a Resource-intensive In-person Doctor-patient Consultation, With a Simple Virtual Care Model That Will Provide a New Standard of Care for Patients on a Direct Oral Anticoagulant or Warfarin and Require Elective Surgery/Procedure.


Sponsor

McMaster University

Enrollment

1,780 participants

Start Date

Dec 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a virtual (online) care model for managing blood thinners (anticoagulants) around the time of surgery is just as safe and effective as in-person care, for people with atrial fibrillation who need an elective procedure. **You may be eligible if...** - You are 18 or older with atrial fibrillation or flutter that requires blood thinners - You take warfarin or one of the direct oral anticoagulants (apixaban, edoxaban, dabigatran, or rivaroxaban) - You are scheduled for an elective surgery or medical procedure **You may NOT be eligible if...** - Your surgery is urgent or an emergency - You take blood thinners for a reason other than atrial fibrillation (e.g., a mechanical heart valve) - You have had a recent blood clot or stroke - You are unable to participate in virtual care appointments 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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Locations(10)

Endeavor Health - Northshore

Evanston, Illinois, United States

Henry Ford

Detroit, Michigan, United States

Northwell Health

Great Neck, New York, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

St. Joesph's Healthcare

Hamilton, Ontario, Canada

Juravinski

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Larissa University Hospital

Larissa, Larisa, Greece

View Full Details on ClinicalTrials.gov

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NCT06844227


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