NCT07515664 Vitamin K for Perioperative Warfarin Management
| NCT ID | NCT07515664 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Michigan |
| Condition | Anticoagulant Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2025-07-03 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.
Eligibility Criteria
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)
Contact & Investigator
Geoffrey Barnes, MD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07515664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anticoagulant Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07515664 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07515664 currently recruiting?
Yes, NCT07515664 is actively recruiting participants. Contact the research team at gbarnes@med.umich.edu for enrollment information.
Where is the NCT07515664 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07515664 clinical trial?
NCT07515664 is sponsored by University of Michigan. The principal investigator is Geoffrey Barnes, MD at University of Michigan. The trial plans to enroll 20 participants.