Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of Quantra Clot Stiffness test results to TEG test results.
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 QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
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 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-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo 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 elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device
- •Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition
- •Subject is ≥ 18 years
- •Subject is willing to participate and he/she has signed a consent form
排除标准
- •Subject is younger that 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 Stiffness test results to TEG test results.
时间窗: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and TEG.
Comparison of Quantra Clot Time test results to TEG test results.
时间窗: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and TEG.
Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results.
时间窗: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and TEG.
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen
时间窗: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count
时间窗: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and platelet count
次要结局
未报告次要终点