What this study is
This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.
What's being tested
- Vitamin K
Intervention · DRUG
10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.
- Warfarin (standard without loading)
Intervention · DRUG
Patients receive their standard warfarin dosing without interruption.
- Warfarin (standard with loading)
Intervention · DRUG
Patients receive their standard warfarin dosing without interruption; patients also receive a one time loading dose (twice normal dose) of warfarin on the evening following their procedure.
Study details
- Official title
- Vitamin K Reversal of INR for Perioperative Management of Warfarin: : A Pilot Study to Assess Feasibility
- Sponsor
- University of Michigan
- Conditions
- Patients Anti-coagulated With Warfarin Who Require Surgery
- Enrolling
- 20 people
- Starts
- 2025-07-03
- Est. completion
- 2026-08
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Warfarin therapy for ≥3 months
- Use of home INR testing equipment
- Scheduled for a surgical procedure that requires INR ≤ 1.5 (typically achieved with warfarin interruption)
- INR ≤ 4 on day 7-10 prior to procedure
You can't join if
- Surgical procedure does not require INR ≤1.5 (typically achieved with warfarin interruption)
- Surgical procedure with a high risk of bleeding or complications (urologic procedures, bronchoscopy, epidural injections, nerve blocks, spinal surgery)
- Warfarin therapy for < 3 months
- Lack of English language proficiency
- Use of a Heartmate II or HVAD left ventricular assist device
- Recent thrombotic event (within 3 months)
- CHA2DS2-VASc score >6
- INR >4 on day 7-10 prior to procedure
- Hypersensitivity to any component of Vitamin K or simple syrup (used in the compounding process)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMichigan Medicine
Ann Arbor, Michigan, United States
- Geoffrey Barnes, MD · Contact734 936-4000gbarnes@med.umich.edu
Recruiting
Study team
Sponsor
University of Michigan
Study ID HUM00264031
Principal investigator
Geoffrey Barnes, MD
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.