Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma
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 the Quantra Clot Time results to standard coagulation test results
研究概览
简要总结
This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients.
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. This includes the trauma patient population. 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 single-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.
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 a trauma patient and is a candidate for a ROTEM test to be performed to access coagulopathy
- •Subject must be experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury.
- •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 weighs less than 110 pounds
- •Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit
- •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 the Quantra Clot Time results to standard coagulation test results
时间窗: Upon arrival to emergency department
Coagulation function assessed by Quantra and standard coagulation tests
Comparison of the Quantra Clot Stiffness results to ROTEM Delta results
时间窗: Upon arrival to emergency department
Coagulation function assessed by Quantra and ROTEM delta
Comparison of the Quantra Clot Stiffness results to standard coagulation test results
时间窗: Upon arrival to emergency department
Coagulation function assessed by Quantra and standard coagulation tests
Comparison of the Quantra Clot Time results to ROTEM Delta results
时间窗: Upon arrival to emergency department
Coagulation function assessed by Quantra and ROTEM delta
Comparison of the Quantra Fibrinolysis results to ROTEM Delta results
时间窗: Upon arrival to emergency department
Coagulation function assessed by Quantra and ROTEM delta
次要结局
未报告次要终点