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

RECRUITINGSponsored by McMaster University
Actively Recruiting
SponsorMcMaster University
Started2021-12-01
Est. completion2025-12-31
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
Locations4 sites

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

Age: 18 Years – 100 YearsHealthy volunteers accepted
Inclusion Criteria:

* Age 18 years of age or older with AF/flutter (chronic, persistent, paroxysmal) that requires anticoagulation
* Receiving warfarin, with a target international normalized ratio (INR) range of 2.0-3.0, or a DOAC, comprising one of the following regimens: apixaban, 2.5 mg or 5 mg bid; edoxaban, 30 mg or 60 mg daily; dabigatran, 110 mg or 150 mg bid; or rivaroxaban, 15 mg or 20 mg daily
* Require an elective (planned, non-urgent) surgery or invasive medical or surgical procedure

Exclusion Criteria:

* Indication for anticoagulation is not AF/flutter (e.g., mechanical heart valve, VTE, other)
* Non-standard anticoagulant regimen used (e.g., warfarin INR 3-4, rivaroxaban 2.5 mg bid)
* In DOAC users only: creatinine clearance \<25 mL/min (that preclude DOAC use)
* Cognitive impairment or psychiatric illness (that precludes reliable contact during follow-up)
* Unable or unwilling to provide consent for virtual care (in-person care will be provided)
* Previous participation in this study for an elective surgery/procedure

Conditions2

Atrial Fibrillation (AF)Heart Disease

Locations4 sites

Illinois

1 site
Endeavor Health - Northshore
Evanston, Illinois, 60201
Marisa Durante(847) 503-6454mdurante@northshore.org

Michigan

1 site
Henry Ford
Detroit, Michigan, 482032
Beverly Stallings313-916-7747bstalli1@hfhs.org

New York

1 site
Northwell Health
Great Neck, New York, 11021
Kanta Ochani(516) 600-1484kochani@northwell.edu

Pennsylvania

1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Alesha Amin469.216.3746alesha.amin@jefferson.edu

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