Vitamin K for Blood Thinner Management

Overseen By Geoffrey Barnes, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Michigan

Must be taking: Warfarin

Disqualifiers: High bleeding risk, Heartmate II, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.

Who Is on the Research Team?

Geoffrey Barnes, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

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)

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

How Is the Trial Designed?

Group I: Standard Warfarin Dosing with Vitamin K Experimental Treatment 2 Interventions

Patients 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.

Group II: Loading Warfarin Dosing with Vitamin K Experimental Treatment 2 Interventions

Patients 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.

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+