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

NCT06844227 | Recruiting DMC

• 2 other identifiers: PAUSE Virtual (CTO 3854)202104PJT-461879-CID-CEBA-5761
• Study Type: observational
• Target: 1,780
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Atrial Fibrillation (AF)

Keywords

anticoagulation; Atrial Fibrillation; Surgery; Oral Anticoagulant; Blood Thinner; DOAC; Interruption; Perioperative; Virtual; PAUSE

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The investigator will determine 30-day post-procedure event rates with 95% confidence interval (CIs) for stroke/systemic embolism (SSE), major bleeding (MB) and, with a one-sided binomial test, will determine in Cohort 1 and Cohort 2 if the SSE rate is lower than 1.5%, and the MB rate is lower than 3%. The investigator will compare patient demographic (e.g., age, gender) and clinical characteristics (e.g., surgery type, SSE/MB risk) in Cohort 1 vs. Control 1 and Cohort 2 vs. Control 2 using Fisher's exact test, respectively, so as to compare SSE and MB in Cohorts and Controls, adjusting for key covariates (e.g., surgery type, anticoagulant type, gender) using multivariate logistic regression. The investigator will determine the proportions (and 95% CIs) for patient satisfaction categories in virtual care and willingness to receive future virtual care.

  From enrollment to end of 30 day follow up

Secondary Outcomes (2)

• Secondary Outcome 1

  From enrollment to end of 30 day follow up

• Secondary Outcome 2

  From enrollment to end of 30 day follow up

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Overall, the study population chosen is justified because: (i) AF/flutter is the dominant clinical indication for anticoagulant therapy; (ii) it is homogenous, thereby optimizing generalizability of study results; and (iii) it allows patient-level comparisons of outcomes with controls from the BRIDGE and PAUSE trials which included AF/flutter (but excluded patients with a MHV or VTE).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (10)

Endeavor Health - Northshore

Evanston, Illinois, 60201, United States

RECRUITING

Henry Ford

Detroit, Michigan, 482032, United States

RECRUITING

Northwell Health

Great Neck, New York, 11021, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

St. Joesph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Juravinski

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Larissa University Hospital

Larissa, Larisa, 413 34, Greece

RECRUITING

Related Publications (89)

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Related Links

• Valentine D GM, Grissinger M. . Valentine D, Gaunt MJ, Grissinger M. Identifying Patient Harm from Direct Oral Anticoagulants. Available from http://patientsafety.pa.gov/ADVISORIES/Pages/201806\_DOACs.aspx. 2020

Biospecimen

Retention: SAMPLES WITHOUT DNA

5 mL whole blood sample, to be processed for plasma that will be frozen and stored at local sites until transfer to the Clinical Research Laboratory \& Biobank at Hamilton Health Sciences, Hamilton, Ontario

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James D Douketis, MD

  McMaster University/St. Joseph's Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James D Douketis, MD

CONTACT

905-522-1155; jdouket@mcmaster.ca

Melanie St John

CONTACT

905-525-9140; stjohm1@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: February 25, 2025
• Study Start: December 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CA (5); GR (1)