Vitamin K Reversal of INR for Perioperative Management of Warfarin: : A Pilot Study to Assess Feasibility
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of patient recruitment
研究概览
简要总结
This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Warfarin (standard without loading) (Drug)
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.
干预措施: Warfarin (standard with loading) (Drug)
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.
干预措施: Vitamin K (Drug)
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.
干预措施: Vitamin K (Drug)
结局指标
主要结局
Feasibility of patient recruitment
时间窗: Within two weeks (from outreach to five days prior to procedure)
Percentage of recruited patients among those initially screened
INR reversal
时间窗: Within 12 hours prior to procedure
Percentage of enrolled patients with an INR less than or equal to 1.5 on morning of procedure
次要结局
- Fidelity to intervention protocol(12 day span from 2 days pre-operative through 10 days post-operative)
- Fidelity to randomization(24 hours (day of procedure))
- Cost per recruited patient(12 day span from 2 days pre-operative through 10 days post-operative)
- Patient acceptability(10 days post procedure)
- Clinical acceptability(10 days post procedure)
- Therapeutic INR by post-operative day 5(day 5 post procedure)
- Adverse events(30 days post procedure)
- Canceled procedures(24 hours prior to procedure)
- Additional warfarin reversal pre-operative(24 hours pre-procedure)
研究者
Geoffrey Barnes
Associate Professor of Internal Medicine
University of Michigan