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 — DRUG10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.
- Warfarin (standard without loading) — DRUGPatients receive their standard warfarin dosing without interruption.
- Warfarin (standard with loading) — DRUGPatients 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 KPatients 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 KPatients 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
- Geoffrey Barnes, MD734 936-4000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Michigan Medicine | Ann Arbor | Michigan | 48109 |
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