Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Liver Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of Quantra Clot Time results to TEG R results
研究概览
简要总结
This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.
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 propoerties of a whole blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects.
This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.
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 of age
- •Subject is undergoing deceased donor liver transplant and is a candidate for a TEG test to be performed to access coagulopathy during surgery.
- •Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)
排除标准
- •Subject is younger than 18 years of age
- •Subject is known to have received antifibrinolytic therapy immediately prior to the start of liver transplantation surgery.
- •Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
- •Subject is currently enrolled in a distinct study that might confound the results of the proposed study
- •Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
结局指标
主要结局
Comparison of Quantra Clot Time results to TEG R results
时间窗: During surgery
Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Stiffness results to TEG MA results
时间窗: During surgery
Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Lysis results to TEG LI30 results
时间窗: During surgery
Coagulation function assessed by Quantra and TEG 5000
次要结局
未报告次要终点