NCT02843958已完成不适用
Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- International Normalized Ratio measurement: comparison to the standard reference.
研究概览
简要总结
This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).
This device was created as an alternative to blood sample, that have to be done in a medical laboratory.
The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •of healthy volunteers:
- •Man or woman between 18 and 70 years
- •Body Mass Index >18 and <29
- •Absence of any acute pathology in the month preceding the study
- •To be affiliated or beneficiary of social security
排除标准
- •of healthy volunteers:
- •Pregnant, partutient or breastfeeding woman
- •Patient with Raynaud's syndrome
- •Person deprived of liberty by legal or administrative decision, person to a legal protection order
- •Deferral periods for other clinical studies
- •Annual threshold compensation attain for biomedical search participations
- •Inclusion Criteria of patients:
- •Man or woman between 18 and 80 years
- •Patient treated by oral anti vitamin K anticoagulants (coumadine, warfarine, fluidione)
- •Absence of any acute pathology in the month preceding the study
- •To be affiliated or beneficiary of social security
- •Exclusion Criteria of healthy patients:
- •Pregnant, partutient or breastfeeding woman
- •Patient with Raynaud's syndrome
- •Person deprived of liberty by legal or administrative decision, person to a legal protection order
- •Deferral periods for other clinical studies
- •Annual threshold compensation attain for biomedical search participations
结局指标
主要结局
International Normalized Ratio measurement: comparison to the standard reference.
时间窗: V2
次要结局
- International Normalized Ratio measurement:reproductibility(V2)
- International Normalized Ratio measurement: repeatability(V2)
研究者
研究点 (2)
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