Vitamin K for Perioperative Warfarin Management
Vitamin K Reversal of INR for Perioperative Management of Warfarin: : A Pilot Study to Assess Feasibility
University of Michigan
20 participants
Jul 3, 2025
INTERVENTIONAL
Conditions
Summary
This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria9
- 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)
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Interventions
10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.
Patients receive their standard warfarin dosing without interruption.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07515664