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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Standard Warfarin Dosing with Vitamin K 		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.
  • Drug: Vitamin K
    10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.
  • Drug: Warfarin (standard without loading)
    Patients receive their standard warfarin dosing without interruption.
    Other names:
    • Coumadin
Experimental
Loading Warfarin Dosing with Vitamin K 		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.
  • Drug: Vitamin K
    10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.
  • Drug: Warfarin (standard with loading)
    Patients receive their standard warfarin dosing without interruption; patients also receive a one time loading dose (twice normal dose) of warfarin on the evening following their procedure.
    Other names:
    • Coumadin

Recruiting Locations

Michigan Medicine
Ann Arbor, Michigan 48109
Contact:
Geoffrey Barnes, MD
734 936-4000
gbarnes@med.umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Geoffrey Barnes, MD
734 936-4000
gbarnes@med.umich.edu

Detailed Description

Historically, warfarin is held for 5 days before a surgical procedure to obtain a safe INR (international normalized ratio) that minimizes bleeding risk. However, there is a strong rationale for continuing warfarin uninterrupted in the perioperative space and giving a one-time vitamin K dose to get a safe INR pre-operatively. This feasibility study will recruit patients who use warfarin and will measure their INR response after receiving a single pre-procedure vitamin K dose. This study will also assess the use of a one-time "loading" dose immediately post-operative to help the INR return to the therapeutic range sooner than continuing with the standard warfarin dosing.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.