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NCT07515664PHASE4Recruiting

Vitamin K for Perioperative Warfarin Management

University of Michigan

Start Date

7/3/2025

Completion Date

8/1/2026

Summary

This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.

Detailed Description

Historically, warfarin is held for 5 days before a surgical procedure to obtain a safe INR (international normalized ratio) that minimizes bleeding risk. However, there is a strong rationale for continuing warfarin uninterrupted in the perioperative space and giving a one-time vitamin K dose to get a safe INR pre-operatively. This feasibility study will recruit patients who use warfarin and will measure their INR response after receiving a single pre-procedure vitamin K dose. This study will also assess the use of a one-time "loading" dose immediately post-operative to help the INR return to the therapeutic range sooner than continuing with the standard warfarin dosing.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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)

Interventions

DRUG

Vitamin K

DRUG

Warfarin (standard without loading)

DRUG

Warfarin (standard with loading)

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Conditions

Anticoagulant Therapy

Locations

Michigan Medicine

Ann Arbor, Michigan 48109

United States