Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reference range intervals for measurement of Clot Stiffness (CS) parameter
研究概览
简要总结
The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
详细描述
This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 18 years or older
- •Subject is willing to participate and has signed a consent form
- •Subject's laboratory coagulation test results at screening are within each test's normal reference range.
排除标准
- •Subject is younger than 18 years
- •Subject has a history of a coagulation disorder
- •Subject is pregnant or lactating
- •Subject is currently taking medications known to alter coagulation
- •Subject has one or more laboratory coagulation test restuls outside of the normal reference range at screening
- •Subject had a blood transfusion or surgery within the last month
- •Drug abuse
- •Excessive alcohol consumption
- •Subject is unable to provide written informed consent
- •Subject is incarcerated at the time of the study
- •Subject previously participated in this study
结局指标
主要结局
Reference range intervals for measurement of Clot Stiffness (CS) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Clot Time (CT) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
时间窗: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available.
次要结局
未报告次要终点