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.

Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Endeavor Health - Northshore
RECRUITING
Evanston
Michigan
Henry Ford
RECRUITING
Detroit
New York
Northwell Health
RECRUITING
Great Neck
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Other Locations
Canada
QEII Health Sciences Centre
RECRUITING
Halifax
Hamilton General Hospital
RECRUITING
Hamilton
Juravinski
RECRUITING
Hamilton
St. Joesph's Healthcare
RECRUITING
Hamilton
The Ottawa Hospital
RECRUITING
Ottawa
Greece
Larissa University Hospital
RECRUITING
Larissa
Contact Information
Primary
James D Douketis, MD
jdouket@mcmaster.ca
905-522-1155
Backup
Melanie St John
stjohm1@mcmaster.ca
905-525-9140
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1780
Treatments
Cohort 1: warfarin-treated patients
Cohort 1: warfarin-treated patients with AF who receive virtual perioperative management
Cohort 2: DOAC-treated patients
Cohort 2: DOAC-treated patients with AF who receive virtual perioperative management.~Using this design, the investigator aims to show in Cohorts 1 and 2 that virtual management is non-inferior to benchmark in-person management, defined by 30-day postoperative rates of SSE ≤0.5% (with 95% confidence to exclude 1.5% rate) and MB ≤1.5% (with 95% confidence to exclude 3% rate).
Related Therapeutic Areas
Sponsors
Leads: McMaster University

This content was sourced from clinicaltrials.gov