Vitamin K for Perioperative Warfarin Management

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Vitamin K
  10 mg of oral vitamin K will be given approximately 36-48 hours before procedure.
• Препарат Warfarin (standard without loading)
  Patients receive their standard warfarin dosing without interruption.
• Препарат 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.

Первичные конечные точки

• Feasibility of patient recruitment [Срок оценки: Within two weeks (from outreach to five days prior to procedure)]
• INR reversal [Срок оценки: Within 12 hours prior to procedure]

Вторичные конечные точки (9)

• Fidelity to intervention protocol [Срок оценки: 12 day span from 2 days pre-operative through 10 days post-operative]
• Fidelity to randomization [Срок оценки: 24 hours (day of procedure)]
• Cost per recruited patient [Срок оценки: 12 day span from 2 days pre-operative through 10 days post-operative]
• Patient acceptability [Срок оценки: 10 days post procedure]
• Clinical acceptability [Срок оценки: 10 days post procedure]
• Therapeutic INR by post-operative day 5 [Срок оценки: day 5 post procedure]
• Adverse events [Срок оценки: 30 days post procedure]
• Canceled procedures [Срок оценки: 24 hours prior to procedure]
• Additional warfarin reversal pre-operative [Срок оценки: 24 hours pre-procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Michigan Medicine — Ann Arbor

Идентификаторы

NCT: NCT07515664 · HUM00264031 · K24HL179410

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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