NCT04842084

Normal Values of Parameters of Thrombin Generation in Function of Different Tissue Factor Concentrations

Determination of Normal Values of Parameters of Thrombin Generation in Fresh PRP and in PPP in Function of Different Tissue Factor Concentrations

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Blood samples	sampling of 10 S-Monovette tubes (Sarstedt) 4.3 ml of blood specifically for the study representing a total blood volume of 43 ml

Timeline

• Start date: 2021-04-23
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2021-04-13
• Last updated: 2023-12-01

Locations

1 site across 1 country: France