Randomized Trial of Reinforcement Learning for the Dosing of Warfarin
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Percent in Range
研究概览
简要总结
This is a clinical study designed to test the hypothesis that a computer model for dosing warfarin is superior to current clinical practice. Subjects will be randomized to two groups based on how warfarin dose is determined and followed for 6 months. The primary outcome is the percent of the time that the INR is maintained in the effective range.
详细描述
This will be a single-center, open-label, randomized prospective study. Primary outcome will be percent of time within a specific INR range. Subjects will be randomized to to control and treatment groups and stratified 1:1 based on sex. The control group will have warfarin doses adjusted by experts in the treatment of patients with warfarin. The treatment group will have warfarin doses determined using a clinical support tool based on reinforcement learning. Based on simulations of the experimental design with an expectation that the percent of INR values within the target range increase by 20%, 70 subjects per group are required for statistical significance. Based on an attrition rate of 15%, the investigators will enroll 80 subjects per group. Statistical analysis will compare the percent of patients within the target INR range between groups as the primary outcome with number of adverse events between groups as the safetly outcome.
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
- Single (Participant)
盲法说明
Subjects will not be informed of group designation
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving anticoagulation treatment with warfarin.
排除标准
- •Pregnancy.
- •History of hemorrhagic cerebrovascular incident.
- •Acquired or inherited hemophilia.
- •Thrombocytopenia (<100,000 platelets per mm3) on 2 occasions separated by 2 days.
- •Anemia with hemoglobin concentration < 10 g/dL.
- •Active cancer excluding non-melanoma skin cancers.
- •Active liver disease as documented by prolonged baseline INR ≥ 1.
- •Uncontrolled hypertension with 2 readings >180/
- •Recent (< 2 weeks) neurosurgical procedure.
- •Enrollment in hospice program for any diagnosis.
结局指标
主要结局
Percent in Range
时间窗: 6 months
Percent of INR measurements within the Target Range
次要结局
- Adverse Events(6 Months)
研究者
Adam Edward Gaweda
Associate Professor
University of Louisville