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NCT06844227Recruiting

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.

Source: ClinicalTrials.gov · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1780 (estimated)
First submitted
25 Nov 2024
Start date
1 Dec 2021
Primary completion date
31 Dec 2025
Lead sponsor
McMaster University
NCT number
NCT06844227

What you commit to

  • Study type: Observational
  • Planned participants: 1780
  • From 1 Dec 2021 to the primary completion date, 31 Dec 2025
  • 10 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous participation in this study for an elective surgery/procedure

Other illness

  • Indication for anticoagulation is not AF/flutter (e.g., mechanical heart valve, VTE, other)
  • Cognitive impairment or psychiatric illness (that precludes reliable contact during follow-up)

Lab values

  • 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)

Other

  • Unable or unwilling to provide consent for virtual care (in-person care will be provided)

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
QEII Health Sciences Centre
Coordinator of this site? Confirm its status
HalifaxCanadaRecruiting
St. Joesph's Healthcare
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HamiltonCanadaRecruiting
Hamilton General Hospital
Coordinator of this site? Confirm its status
HamiltonCanadaRecruiting
Juravinski
Coordinator of this site? Confirm its status
HamiltonCanadaRecruiting
The Ottawa Hospital
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting
Larissa University Hospital
Coordinator of this site? Confirm its status
LarissaGreeceRecruiting
Henry Ford
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
Endeavor Health NorthShore
Coordinator of this site? Confirm its status
EvanstonUnited StatesRecruiting
Northwell Health
Coordinator of this site? Confirm its status
Great NeckUnited StatesRecruiting
Thomas Jefferson University Hospital
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.