Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays
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 QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results
研究概览
简要总结
This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.
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 (previously called the Surgical Cartridge), was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge provides six parameters that depict the functional status of a patient's coagulation system.
This single site, prospective observational study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests (PT, aPTT, fibrinogen, platelet count) in cardiac surgery patients. As an additional exploratory study, the association of Quantra-derived parameters with select platelet function tests will be investigated.
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 undergoing elective cardiac surgery with cardiopulmonary bypass
- •Subject is willing to participate and has signed a consent form
排除标准
- •Subject is younger than 18 years
- •Subject has known congenital coagulopathy
- •Subject is unable to provide written informed consent
结局指标
主要结局
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results
时间窗: Baseline (before surgery)
Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta
时间窗: After cardiac bypass (10 minutes after administration of protamine)
Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta
Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results
时间窗: After cardiac bypass (10 minutes after administration of protamine)
Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests
次要结局
- Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest(After cardiac bypass (10 minutes after administration of protamine))