NCT07515664

Vitamin K for Perioperative Warfarin Management

Vitamin K Reversal of INR for Perioperative Management of Warfarin: : A Pilot Study to Assess Feasibility

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anticoagulant Therapy

Interventions

Type	Name	Description
DRUG	Vitamin K	10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.
DRUG	Warfarin (standard without loading)	Patients receive their standard warfarin dosing without interruption.
DRUG	Warfarin (standard with loading)	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.

Timeline

• Start date: 2025-07-03
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-04-07
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study