Determination of Normal Values of Parameters of Thrombin Generation in Fresh PRP and in PPP in Function of Different Tissue Factor Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Thrombin generation parameter in PRP (V : nmol/min)
研究概览
简要总结
The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP).According to the clinical context, different TF(Tissue Factor) concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.The aim of the study is to determine the normal values of TG (Thrombin Generation) in fresh PRP and in PPP with different TF concentrations.
详细描述
The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma. TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP). The thrombin generation (TG) profile varies from patient to patient and depends on the activity of the pro and anti-coagulant factors. The TGA values depend on the analytical conditions such as Tissue Factor (TF) concentration and the plasma analyzed (PRP or PPP). According to the clinical context, different TF concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.
As a consequence, the reference values vary with the analytical conditions but also with the studied population (men or women). The reference values are not provided by the manufacturer and each laboratory has to establish the normal values according to the analytical conditions chosen for the pathology explored (hemorrhagic or thrombotic). Moreover, in PPP, the TG results can be different according to batch reagents. That is the reason why plasma will be frozen for a new determination in case of deviation of the result of the control plasma.
The aim of the study is to determine the normal values of TG in fresh PRP and in PPP with different TF concentrations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient beneficiary or affiliated to Social security system
- •Consent signed
排除标准
- •Personal or family history (parents, brothers, sisters) of hemorrhage
- •Personal or family history (parents, brothers, sisters) of thrombosis before 45 years old
- •Taking an anti-inflammatory or an aspirin one week before the sampling
- •Current take of an anticoagulant or antiaggregant treatment
- •Surgery within previous month before the sampling
- •Chronic pathology responsible of an inflammatory syndrome
- •Episode of viral or bacterial infections
- •Known HIV or Hepatitis C Virus (HCV) infection
- •Participation in a therapeutic clinical trial
结局指标
主要结局
Thrombin generation parameter in PRP (V : nmol/min)
时间窗: At inclusion
Velocity index measurement
Thrombin generation parameter in PRP (Peak : nmol thrombin)
时间窗: At inclusion
Peak measurement
Thrombin generation parameter in PRP (ETP : nmol*min)
时间窗: At inclusion
Endogenous Thrombin Potential measurement
Thrombin generation parameter in PRP (LT : min)
时间窗: At inclusion
Lag Time measurement
Thrombin generation parameter in PRP (TTP : min)
时间窗: At inclusion
Time to Peak measurement
Thrombin generation parameter in PRP (ST : min)
时间窗: At inclusion
Start Tail measurement
次要结局
- Thrombin generation parameters in PPP (V : nmol/min)(At inclusion)
- Thrombin generation parameters in PPP (TTP : min)(At inclusion)
- Thrombin generation parameters in PPP (ETP : nmol*min)(At inclusion)
- Thrombin generation parameters in PPP (ST: min)(At inclusion)
- Thrombin generation parameters in PPP (Peak : nmol thrombin)(At inclusion)
- Thrombin generation parameters in PPP (LT: min)(At inclusion)