Comparison of Coagulation Parameters in Arterial and Venous Blood Measured Using the Quantra System
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 Clot Time and Clot Stiffness results between arterial and venous samples
研究概览
简要总结
The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.
详细描述
The Quantra System is a fully integrated and automated in vitro diagnostic device which utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic changes in the viscoelastic properties of a blood sample during coagulation and clot lysis. Viscoelastic testing performed using existing technologies is typically performed on arterial samples obtained from patients undergoing surgical procedures, although reference ranges for these tests have been established for venous blood only.
The aim of this study is to evaluate potential differences between Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.
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 scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
- •Subject is ≥18 years
- •Subject is willing to participate and he/she has signed a consent form
- •Subject may participate if they have a history of bleeding or are on preoperative anticoagulant therapy
排除标准
- •Subject is unable to provide written informed consent
- •Subject is younger than 18 years
- •Subject is incarcerated at the time of the study
- •Subject is currently enrolled in a study that may confound the results 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 Clot Time and Clot Stiffness results between arterial and venous samples
时间窗: Up to 24 hours
Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass)
次要结局
- Comparison of Quantra results to comparable ROTEM results in venous samples(Up to 24 hours)
- Comparison of Quantra results to standard coagulation test results in venous samples(Up to 24 hours)