Exploratory Assessment of the Quantra® System With the QPlus® and QStat® Cartridges in Adult ECMO Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Comparison of Quantra Clot Time results to standard coagulation test results.
研究概览
简要总结
This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.
详细描述
Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.
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
- 否
入选标准
- •Subject is > 18 years.
- •Subject is scheduled to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours.
- •Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.
排除标准
- •Subject is younger than 18 years of age.
- •Subject is pregnant.
- •Subject is incarcerated at the time of the study.
- •Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
- •Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.
结局指标
主要结局
Comparison of Quantra Clot Time results to standard coagulation test results.
时间窗: 6 hours after the previous measurment
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Comparison of Quantra Clot Stiffness results to standard coagulation test results.
时间窗: 6 hours after the previous measurment
Coagulation function assessed by Quantra and standard-of-care coagulation tests
次要结局
未报告次要终点