Health TrialsbyHealthPanel

Vitamin K for Perioperative Warfarin Management

ConditionAnticoagulant Therapy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin K

    Drug

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Standard Warfarin Dosing with Vitamin KExperimental treatment 2 interventions
Group B: Loading Warfarin Dosing with Vitamin KExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)
2

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

1

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
2

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)
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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