Virtual management of anticoagulant therapy for patients needing elective surgery
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.
This study is testing if virtual visits can safely manage blood thinner therapy for patients with atrial fibrillation who need elective surgery, instead of having them come in for in-person appointments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1780 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 10 sites (Evanston, Illinois and 9 other locations) |
| Trial ID | NCT06844227 on ClinicalTrials.gov |
What this trial studies
The PAUSE-Virtual study aims to evaluate the safety and effectiveness of managing anticoagulant therapy for patients with atrial fibrillation who require elective surgery through virtual visits instead of traditional in-person consultations. This observational study will assess whether virtual appointments can provide the same level of care and safety in terms of stroke and bleeding risks as in-person visits. Participants will receive guidance on when to stop and restart their blood thinners and instructions on self-administering short-acting anticoagulants if necessary. The study is particularly relevant in the context of changes in healthcare delivery due to the COVID-19 pandemic.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with atrial fibrillation who are on anticoagulant therapy and require elective surgery.
Not a fit: Patients whose anticoagulation is indicated for conditions other than atrial fibrillation or those with cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could streamline pre-surgery management for patients on blood thinners, making it more accessible and convenient.
How similar studies have performed: Previous studies have indicated that virtual care can be effective in managing various health conditions, suggesting potential success for this novel approach in anticoagulant management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Evanston, Illinois and 9 other locations
- Endeavor Health - Northshore — Evanston, Illinois, United States (Recruiting)
- Henry Ford — Detroit, Michigan, United States (Recruiting)
- Northwell Health — Great Neck, New York, United States (Recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- QEII Health Sciences Centre — Halifax, Nova Scotia, Canada (Recruiting)
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
- St. Joesph's Healthcare — Hamilton, Ontario, Canada (Recruiting)
- Juravinski — Hamilton, Ontario, Canada (Recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- Larissa University Hospital — Larissa, Larisa, Greece (Recruiting)
Study contacts
- Principal investigator: James D Douketis, MD — McMaster University/St. Joseph's Healthcare
- Study coordinator: James D Douketis, MD
- Email: jdouket@mcmaster.ca
- Phone: 905-522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.