Impact of Sample Type on the Performance of the Quantra QStat System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Comparison of QStat Clot time (CT) in arterial and venous samples
研究概览
简要总结
This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.
详细描述
In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.
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 liver transplant surgery
- •Subject or subject's legally authorized representative (LAR) is willing to provide 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 affected by a condition that, in the opinion of the treatment team, may pose additional risks
- •Subject, or subject's LAR, is unable or unwilling to provide informed consent
结局指标
主要结局
Comparison of QStat Clot time (CT) in arterial and venous samples
时间窗: During liver transplantation surgery
Coagulation function assessed in two sample types
Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples
时间窗: During liver transplantation surgery
Coagulation function assessed in two sample types
Comparison of QStat Clot stiffness (CS) in arterial and venous samples
时间窗: During liver transplantation surgery
Coagulation function assessed in two sample types
Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
时间窗: During liver transplantation surgery
Coagulation function assessed in two sample types
Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples
时间窗: During liver transplantation surgery
Coagulation function assessed in two sample types
次要结局
未报告次要终点