Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 3
- 主要终点
- Reference range intervals for measurement of Clot Time, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System
研究概览
简要总结
This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.
详细描述
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra Surgical Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. In this multi-center, prospective, observational study, blood samples will be obtained from healthy adult volunteers to establish a normal reference range for the test parameters measured by the Quantra System.
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
- •Subject is willing to participate and he/she 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 had a blood transfusion or surgery within the last month
- •Subject has one or more laboratory coagulation test result outside of the normal reference range at screening
- •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 Time, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System
时间窗: Baseline, determined from single blood draw
Reference range intervals determined in this study from the analysis of blood samples collected from healthy adults will serve as the initial reference ranges for the Quantra test parameters when the Surgical Cartridge is commercially available.
次要结局
未报告次要终点