Vitamin K for Perioperative Warfarin Management (NCT07515664) | Clinical Trial Compass
RecruitingPhase 4
Vitamin K for Perioperative Warfarin Management
United States20 participantsStarted 2025-07-03
Plain-language summary
This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Feasibility of patient recruitment
Timeframe: Within two weeks (from outreach to five days prior to procedure)