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临床试验/NCT01024452
NCT01024452已完成3 期

Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System

Population Health Research Institute2 个研究点 分布在 1 个国家目标入组 1,298 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,298
试验地点
2
主要终点
TTR: The proportion of time a patient spends in the therapeutic INR range (2-3)

研究概览

简要总结

Randomized comparison of warfarin dosing quality between the Hamilton nomogram and a commercial computer system.

Hypothesis: Mean TTR of patients managed with the commercial computer system is non-inferior to management with the validated Hamilton Nomogram.

详细描述

Warfarin has a variable effect and many potential food and drug interactions. To have an optimal therapeutic effect the International Normalized Ratio (INR) needs to be maintained within the therapeutic target range. The time that a patient spends within the therapeutic target range is an intermediate quality indicator for patient outcomes and should be optimized. For this purpose, we use in our anticoagulation clinic the simple two-step Hamilton nomogram, which has been validated by Kim et al. who showed that the nomogram improved INR control for warfarin maintenance compared with expertise-based dosing in our anticoagulation clinic (see references). Computer systems are also known to outperform expertise-based dosing, but no direct comparison of a computer system with a simple nomogram has been assessed. In this single-center randomized controlled clinical trial we will compare the simple two-step Hamilton nomogram with the widely used computerized dosing management system DAWN AC regarding their effect on time in therapeutic range for patients on maintenance dosing with target range 2-3.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • On warfarin maintenance therapy
  • INR target range 2-3
  • At least 3 historical INRs on maintenance therapy
  • At least 1 historical INR in the last 3 months

排除标准

  • Participation in another study
  • On multiple pill strengths

结局指标

主要结局

TTR: The proportion of time a patient spends in the therapeutic INR range (2-3)

时间窗: TTR calculated over the entire study period (6 months)

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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