Evaluation of the Diagnostic Performances of the TEG 6s® Hemostasis Device and Its Platelet Mapping® Cartridge for Perioperative Monitoring of Platelet Function During Cardiopulmonary Bypass for Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Compare the diagnostic performance of the TEG®6S device and its Platelet mapping cartridge with that of the reference tests used in the hematology laboratory for the evaluation of platelet function
研究概览
简要总结
Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.
详细描述
Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients scheduled to undergo cardiopulmonary bypass
- •Informed consent
排除标准
- •Age <18 years
- •Pregnant women
- •Emergency surgery
- •Cardiac surgery without CPB
- •thrombocytopenia <100000/mmm3
结局指标
主要结局
Compare the diagnostic performance of the TEG®6S device and its Platelet mapping cartridge with that of the reference tests used in the hematology laboratory for the evaluation of platelet function
时间窗: 6 hours after inclusion
Comparison of the results of reference tests used in the hematology laboratory for the evaluation of platelet function such as the results of total blood aggregometry by impedance (Multiplate®: TRAPtest, ASPItest and ADPtest), with the results of the TEG® Platelet mapping® cartridge (MA fibrin, MA-ADP, MA-AA) obtained at the different pre, per and post-extracorporeal circulation sampling times
次要结局
- Compare the diagnostic performance of the TEG®6S device and its Platelet mapping® cartridge with the reference tests used in the hematology laboratory for the prediction of the risk of post-cardiopulmonary bypass bleeding.(24 hours after inclusion)
- Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass(24 hours after inclusion)