Vitamin K for Perioperative Warfarin Management

Phase 4RecruitingNCT07515664

University of Michigan20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anticoagulant Therapy

Interventions

Vitamin KDRUG

10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.

Warfarin (standard without loading)DRUG

Patients receive their standard warfarin dosing without interruption.

Warfarin (standard with loading)DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Michigan Medicine

Ann Arbor, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

Feasibility of patient recruitment

Percentage of recruited patients among those initially screened

Time frame: Within two weeks (from outreach to five days prior to procedure)

INR reversal

Percentage of enrolled patients with an INR less than or equal to 1.5 on morning of procedure

Time frame: Within 12 hours prior to procedure

Secondary Outcomes

Fidelity to intervention protocol

Percent of patients who achieved both elements of the intervention: 1) continued warfarin uninterrupted peri-operatively; 2) Administration of oral vitamin K on the evening of pre-operative day 2

Time frame: 12 day span from 2 days pre-operative through 10 days post-operative

Fidelity to randomization

Percent of patients who used the appropriate dose of warfarin that was recommended immediately post -procedure based on randomization

Time frame: 24 hours (day of procedure)

Cost per recruited patient

Study costs per patient recruited through end of follow up. Inclusive of personnel, supplied, medication costs.

Time frame: 12 day span from 2 days pre-operative through 10 days post-operative

Patient acceptability

Data gathered with an acceptability survey, measured on a Likert scale ranging from 1-5 where 5 means most acceptable and 1 means least acceptable.

Time frame: 10 days post procedure

Clinical acceptability

Data gathered with an acceptability survey, on a Likert scale ranging from 1-5 where 5 means most acceptable and 1 means least acceptable.

Central Contacts

Geoffrey Barnes, MD

CONTACT

734 936-4000 gbarnes@med.umich.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.