A Single-site, Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Patients With Unstable Warfarin Effect.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Improvement in TTR
研究概览
简要总结
Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematician Michael Fearon), which uses historical data to estimate patients' sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment takes effect, or to the investigators standard management Main outcome is improvement in time in therapeutic range.
详细描述
Patients with very variable INRs resulting in a low proportion of time in therapeutic range (TTR) have a higher risk of both bleeding complications and thromboembolic events. A good TTR is generally considered to be over 60% and "excellent TTR" is above 72% of time in range. The investigators will recruit patients with a TTR below 50%.
The Fearon algorithm provides a more thorough understanding of the individual responses to changes in warfarin dose and with a personalized nomogram for dose adjustments and timing of laboratory tests the investigators have an opportunity to improve the TTR and on a larger scale to reduce clinically important adverse events. Before embarking on a large randomized trial with this revised Fearon algorithm-derived nomogram this pilot study with a randomized, open-label design will be performed to demonstrate proof of principle.
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
- •Patients with mechanical heart valve prosthesis managed for the warfarin therapy by the Thrombosis Service at HHS-General Hospital.
- •Treated with warfarin for at least 1 year.
- •Therapeutic INR range 2.0-3.0 or 2.5-3.
- •TTR in the lowest quartile
排除标准
- •Known poor compliance due to for example alcohol abuse or cognitive impairment
- •Refusal to provide written informed consent
研究组 & 干预措施
Fearon algorithm dosing
Warfarin adjustment using the Fearon algorithm
干预措施: Warfarin adjustment using the Fearon algorithm (Other)
Standard dosing
Warfarin adjustment using standard dosing
干预措施: Warfarin adjustment using standard dosing (Other)
结局指标
主要结局
Improvement in TTR
时间窗: 6 months
The percent units of TTR during the 6 months will be compared with the percent units TTR in the previous year
次要结局
- Proportion of patients with improvement in TTR(6 months)