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Vitamin K for Perioperative Warfarin Management

Vitamin K for Perioperative Warfarin Management

Recruiting
18 years and older
All
Phase 4

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Overview

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

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

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)

Study details
    Anticoagulant Therapy

NCT07515664

University of Michigan

13 May 2026

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