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临床试验/NCT01349712
NCT01349712Unknown不适用

Correlation of Feasibility Batches Using Warfarinised Blood

Universal Biosensors Pty Ltd1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device

研究概览

简要总结

The purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.

详细描述

This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Currently taking coumadin (warfarin)
  • Aged 18 years or older
  • Able and willing to provide informed consent
  • Can understand (read and write) English

排除标准

  • 未提供

结局指标

主要结局

PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device

时间窗: Fives days to collect data and up to two weeks to generate correlation graph

To determine the correlation of PT/INR values between an experimental and commercial device.

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (1)

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