Prospective Trial of a Validated Algorithm for Warfarin Dosing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 主要终点
- Time in therapeutic range
研究概览
简要总结
The aim of this study is to perform a randomized trial comparing the use of the algorithm, with dosing of warfarin in standard manual dosage clinical practice, in a high quality anticoagulant setting (PSM). This is done for safety concerns and to ensure good performance of the algorithm when used in a clinical setup. The results from the study are expected to increase our knowledge of efficacy by using the algorithm in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Participants will be those ≥18 years old, must refer to Trombosecenter Aalborg and have to be educated as PSM patient
- •Have to be treated for at least 1 month and willing to sign informed consent
排除标准
- •OAT treatment with phenprocoumon
- •Lack of ability to handle the interface on the software used in the study (evaluated by the investigator present at the information meeting)
- •Pregnancy
- •Those with severe co-morbidities (e.g., creatinine > 2.5, hepatic insufficiency, active malignancy, advanced physiological age, noncompliance risk, expected survival <6 months), and physician or patient preference.
研究组 & 干预措施
self-managing warfarin
self-managing warfarin patients who are educated in dosing warfarin to achieve target INR value
干预措施: Active Comparator (Other)
algorithm-suggested warfarin dosing
algorithm-suggested warfarin dosing, where the participants are provided with a dosage suggestion of their warfarin dosage (calculated dose) to achieve target INR
干预措施: Experimental (Other)
结局指标
主要结局
Time in therapeutic range
时间窗: 6 months
The primary study endpoint, TTR, was calculated according to the Rosendaal method
次要结局
- Log of the variance growth rate(6 months)
研究者
Peter Brønnum
Postdoc, PhD
Aalborg University Hospital