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New treatment option for Anticoagulant Therapy
Official title Vitamin K for Perioperative Warfarin Management
ClinicalTrials.gov ID: NCT07515664
What this study is testing
What is Vitamin K?
Vitamin K is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anticoagulant therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.