NCT02205827已完成不适用
A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年4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
- 12
- 试验地点
- 2
- 主要终点
- Variability in whole blood clotting time measurement
研究概览
简要总结
The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians.
详细描述
No investigational product was administered to any subject in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
- •Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
排除标准
- •Healthy subjects who do not conform to the above inclusion criteria.
- •Healthy subjects who cannot communicate reliably with the Investigator.
- •History of major bleeding or major trauma within the past 6 months
- •Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
- •Significant infection or known inflammatory process within 2 weeks of screening.
- •Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
- •Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
- •Unwillingness or inability to comply with procedures required in this protocol.
- •Subjects who are concurrently enrolled in any other clinical study.
结局指标
主要结局
Variability in whole blood clotting time measurement
时间窗: 1 day
Assessment of variability in whole blood clotting time measurements in human blood collected from volunteers in across five technicians
次要结局
未报告次要终点
研究者
研究点 (2)
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