HemoSonics - UTMB Cardiac Surgery Study
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 standard coagulation test results (aPTT)
研究概览
简要总结
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
详细描述
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, and ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus 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.
This single-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable 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
- •Subject is scheduled for cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
- •Subject is willing to participate, and he/she has signed a consent form.
排除标准
- •Subject is younger than 18 years
- •Subject is unable to provide written informed consent
- •Subject is incarcerated at the time of the study
- •Subject is pregnant
- •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 standard coagulation test results (aPTT)
时间窗: Post-bypass, defined as 10 to 20 minutes after protamine administration
Coagulation function assessed by Quantra and standard coagulation tests
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
时间窗: Post-bypass, 10 to 20 minutes after protamine
Coagulation function assessed by Quantra and standard coagulation tests
Comparison of Quantra Clot Stiffness results to TEG MA results
时间窗: Post-bypass, defined as 10 to 20 minutes after protamine administration
Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Time results to TEG R results
时间窗: Post-bypass, defined as 10 to 20 minutes after protamine administration
Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
时间窗: Post-bypass, defined as 10 to 20 minutes after protamine administration
Coagulation function assessed by Quantra and standard coagulation tests
次要结局
未报告次要终点