Vitamin K for Perioperative Warfarin Management

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07515664
Phase
PHASE4
Status
Recruiting

Conditions

  • Anticoagulant Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

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

Key Dates

Start date
Jul 3, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard Warfarin Dosing with Vitamin K
    Patients will receive their standard warfarin dosing before, during, and after their procedure. This is in addition to a one time dose of oral vitamin K pre-procedure.
  • Experimental: Loading Warfarin Dosing with Vitamin K
    Patients will receive their standard warfarin dosing before and during their procedure. On the night following the procedure, they will receive a one time loading dose of warfarin (twice their normal dose). Patients will then resume normal dosing of warfarin. This is in addition to a one time dose of oral vitamin K pre-procedure.

Primary Outcome Measure

Feasibility of patient recruitment [ Time Frame: Within two weeks (from outreach to five days prior to procedure) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Michigan MedicineAnn ArborMichigan48109
Geoffrey Barnes, MD
734 936-4000

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