Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 10
- 主要终点
- Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
研究概览
简要总结
This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.
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 QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.
This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.
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 a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
- •Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed 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 is currently enrolled in a distinct study that might confound the result of the proposed study
- •Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks.
结局指标
主要结局
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
时间窗: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
时间窗: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
时间窗: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
时间窗: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
次要结局
未报告次要终点