20 Participants NeededMy employer runs this trial

Vitamin K for Blood Thinner Management

GB
Overseen ByGeoffrey Barnes, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Michigan
Must be taking: Warfarin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a one-time dose of Vitamin K can help individuals on warfarin, a common blood thinner, manage their medication before surgery. Researchers aim to determine if maintaining uninterrupted warfarin, with the addition of Vitamin K, is feasible and safe. Participants are divided into two groups: one receives their usual dose plus Vitamin K, while the other receives a higher dose of warfarin after surgery along with Vitamin K. Ideal candidates for this trial have been on warfarin for at least 3 months, use home equipment to monitor blood thickness, and are planning surgery that typically requires stopping warfarin. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it focuses on continuing warfarin while adding a one-time dose of Vitamin K. It seems likely you will continue your warfarin therapy.

What is the safety track record for Vitamin K?

Research has shown that vitamin K is generally safe for people. One study found that taking a low dose of vitamin K orally is safe and helps manage high INR levels, which measure blood clotting time. Another study found that a small dose of vitamin K helped people who had trouble maintaining steady INR levels. This suggests vitamin K can aid blood clotting without causing major side effects.

However, vitamin K can interact with warfarin, a common blood thinner, potentially reducing its effectiveness if not managed properly. Doctors are aware of this interaction and usually consider it when prescribing vitamin K with warfarin.

Overall, vitamin K is well tolerated, especially under medical supervision. It's important to follow a doctor's advice when using it with other medications like warfarin.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Vitamin K in combination with warfarin for blood thinner management because it could enhance the safety and effectiveness of anticoagulation during procedures. Unlike standard care, which primarily focuses on adjusting warfarin doses, this approach includes a one-time dose of Vitamin K to potentially stabilize blood clotting. Additionally, one treatment arm includes a loading dose of warfarin post-procedure, which might optimize anticoagulation control more quickly. These strategies aim to reduce bleeding risks and improve outcomes for patients undergoing procedures while on blood thinners.

What evidence suggests that Vitamin K might be an effective treatment for blood thinner management?

This trial will compare two approaches to warfarin dosing with the addition of vitamin K. Studies have shown that adding vitamin K can stabilize blood thinning for people taking warfarin. For individuals struggling to maintain steady blood thinning levels, vitamin K improved their results. Research indicates that regular vitamin K consumption leads to more stable blood thinning levels. While some evidence suggests vitamin K supplements might help, further research is needed to confirm all the benefits. Overall, vitamin K has stabilized blood thinning in warfarin users, aiding in more effective treatment management.12367

Who Is on the Research Team?

GB

Geoffrey Barnes, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults on warfarin for at least 3 months, who use home INR testing and have an INR of 4 or less a week before surgery. They must be scheduled for surgery that usually requires stopping warfarin to lower bleeding risk. People with recent blood clots, certain heart devices, allergies to vitamin K, high bleeding risk surgeries, or poor English can't join.

Inclusion Criteria

Use of home INR testing equipment
INR ≤ 4 on day 7-10 prior to procedure
I have been taking warfarin for at least 3 months.
See 1 more

Exclusion Criteria

I have had a blood clot in the past 3 months.
Use of a Heartmate II or HVAD left ventricular assist device
Hypersensitivity to any component of Vitamin K or simple syrup (used in the compounding process)
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Pre-operative Management

Participants receive a one-time dose of oral vitamin K to achieve a safe INR before the surgical procedure

5 days
1 visit (in-person)

Surgical Procedure and Immediate Post-operative Management

Participants undergo the surgical procedure and receive a one-time loading dose of warfarin post-operatively

1 day
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for INR levels and adverse events, with follow-up surveys for acceptability

10 days
2 visits (in-person), 1 survey (virtual)

Follow-up

Participants are monitored for safety and effectiveness, including adverse events up to 30 days post-procedure

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Vitamin K

Trial Overview

The study tests if giving a single dose of vitamin K while continuing regular warfarin (with or without loading) before surgery can safely manage blood thinning without fully stopping the medication. It's designed as a feasibility study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Standard Warfarin Dosing with Vitamin KExperimental Treatment2 Interventions
Group II: Loading Warfarin Dosing with Vitamin KExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Vitamin K for improved anticoagulation control in patients ...

This study found that in the group of participants deemed to have poor INR control, the addition of 150 micrograms (mcg) oral vitamin K significantly improved ...

Daily vitamin K supplementation improves anticoagulant ...

Research suggests that patients with a low dietary intake of vitamin K have a less stable anticoagulant control than patients with a higher intake.

Vitamin K for improved anticoagulation control in patients ...

Currently, there are insufficient data to suggest an overall benefit. Larger, higher quality trials are needed to examine if low‐dose vitamin K ...

Pharmacology of Warfarin

Though effective, high doses of vitamin K1 (eg, 10 mg) may lower the INR more than necessary and lead to warfarin resistance for up to a week. Vitamin K1 can be ...

Warfarin and vitamin K intake in the era of pharmacogenetics

Dietary and supplemental vitamin K consumption is a controllable contributor to within-, and between-patient variability of warfarin sensitivity.

Warfarin and Vitamin K - My Health Alberta

Vitamin K normally helps your blood clot so wounds don't bleed too much. Warfarin works against vitamin K. It makes your blood clot more slowly.

Management of Excessive Anticoagulant Effect Due to Vitamin ...

Failure to administer vitamin K may cause the INR to rise, usually 12 to 24 hours after initial treatment because the half-life of warfarin far ...