Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
研究概览
简要总结
This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.
详细描述
In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus 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 scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
- •Subject is ≥18 years
- •Subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr.
排除标准
- •Subject is younger than 18 years
- •Subject is pregnant
- •Subject is incarcerated at the time of the study
- •Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
- •Subject, or subject's legally aurthorized representative is able to provide written informed consent
结局指标
主要结局
Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
时间窗: During cardiac surgery
Measure of the shear modulus or strength/quality of the clot contributed by platelets determined using SEER sonorheometry assessed in two sample types
Comparison of QPlus Clot time (CT) in arterial and venous samples
时间窗: During cardiac surgery
Coagulation function assessed in two sample types
Comparison of Clot stiffness (CS) determined with Quantra QPlus Cartridge in arterial and venous samples
时间窗: During cardiac surgery
Measure of the overall shear modulus or strength/quality of the clot determined using SEER sonorheometry assessed in two sample types
Comparison of QPlus Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples
时间窗: During cardiac surgery
Measure of the shear modulus or strength/quality of the clot contributed by fibrinogen determined using SEER sonorheometry assessed in two sample types
Comparison of QPlus Clot time with Heparinase (CTH) in arterial and venous samples
时间窗: During cardiac surgery
Coagulation function assessed in two sample types
次要结局
未报告次要终点