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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00293-38 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy volunteers | Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Biological | sampling of 10 S-Monovette tubes (Sarstedt) 4.3 ml of blood specifically for the study representing a total blood volume of 43 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thrombin generation parameter in PRP (Peak : nmol thrombin) | Peak measurement | At inclusion |
| Thrombin generation parameter in PRP (ETP : nmol*min) | Endogenous Thrombin Potential measurement | At inclusion |
| Thrombin generation parameter in PRP (LT : min) | Lag Time measurement | At inclusion |
| Thrombin generation parameter in PRP (V : nmol/min) | Velocity index measurement | At inclusion |
| Thrombin generation parameter in PRP (TTP : min) | Time to Peak measurement | At inclusion |
| Thrombin generation parameter in PRP (ST : min) | Start Tail measurement | At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombin generation parameters in PPP (Peak : nmol thrombin) | Peak measurement | At inclusion |
| Thrombin generation parameters in PPP (ETP : nmol*min) | Endogenous Thrombin Potential measurement |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old,
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Tardy, MD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne - Service d'Hématologie | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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plasma
| At inclusion |
| Thrombin generation parameters in PPP (LT: min) | Lag Time measurement | At inclusion |
| Thrombin generation parameters in PPP (V : nmol/min) | Velocity index measurement | At inclusion |
| Thrombin generation parameters in PPP (TTP : min) | Time to Peak measurement | At inclusion |
| Thrombin generation parameters in PPP (ST: min) | Start Tail measurement | At inclusion |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |