A Prospective, Single-Center Study, in Healthy Volunteers to Establish a PT/INR Reference Interval for the Microvisk INR Test System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- INR value for normal population
研究概览
简要总结
This is a prospective, single-center study in healthy volunteers to establish a PT/INR reference interval for the Microvisk International Normalized Ratio (INR) Test System. The primary objective of this study is to establish the reference interval for the measurement of prothrombin time (PT/INR) using the Microvisk INR Test System. The second objective is to evaluate the safety of the device.
详细描述
Healthy volunteers who meet eligibility criteria, have been fully informed and provided written informed consent will be enrolled into this study. Each participant will be required to donate up to 3 finger stick samples for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. This will be followed by a standard venipuncture for (1) a neutral tube (Red Top) for analysis by the on-test method, (1) one sodium citrate tube (Blue Top) for analysis by the comparative/reference laboratory method. Sample collection will take place within the clinic session. The maximum trial duration for each participant is one clinic session.
研究设计
- 研究类型
- Observational
- 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
- 是
入选标准
- •Subject is considered a healthy volunteer
- •Subject is male or female, over 18 years of age
- •Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent
- •Subject agrees to have blood drawn (venipuncture) and finger stick
排除标准
- •Subject is unable to give informed consent
- •Subject is less than 18 years of age
- •Female subject is pregnant
- •Subject is on anticoagulant medication or other medication known to affect PT/INR assessment (e.g., warfarin, heparin) for a minimum of 28 days before enrolling in the trial
- •Subject has a medical condition known to affect PT/INR (e.g. vitamin K deficiency, disseminated intravascular coagulation, liver disease, decreased or defective factor I, II, V, VII, or X)
- •Subject has already taken part in the study
结局指标
主要结局
INR value for normal population
时间窗: 1 day
Establish the INR value for the normal population
次要结局
- Device Failure (number of device failures)(up to 12 weeks)
- Safety (Number of Participants with Adverse Events)(1 day)