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Recruiting NCT07515664

Vitamin K for Perioperative Warfarin Management

Phase IV Interventional Anticoagulant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin K, Warfarin (standard without loading), Warfarin (standard with loading).
Who it may be relevant to
Registry conditions: Anticoagulant Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vitamin K Reversal of INR for Perioperative Management of Warfarin: : A Pilot Study to Assess Feasibility

Overview

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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Feasibility of patient recruitment [Time frame: Within two weeks (from outreach to five days prior to procedure)]
  • INR reversal [Time frame: Within 12 hours prior to procedure]
Secondary outcome measures (9)
  • Fidelity to intervention protocol [Time frame: 12 day span from 2 days pre-operative through 10 days post-operative]
  • Fidelity to randomization [Time frame: 24 hours (day of procedure)]
  • Cost per recruited patient [Time frame: 12 day span from 2 days pre-operative through 10 days post-operative]
  • Patient acceptability [Time frame: 10 days post procedure]
  • Clinical acceptability [Time frame: 10 days post procedure]
  • Therapeutic INR by post-operative day 5 [Time frame: day 5 post procedure]
  • Adverse events [Time frame: 30 days post procedure]
  • Canceled procedures [Time frame: 24 hours prior to procedure]
  • Additional warfarin reversal pre-operative [Time frame: 24 hours pre-procedure]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Michigan Medicine — Ann Arbor

Identifiers

NCT: NCT07515664 · HUM00264031 · K24HL179410

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗