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

Study Overview
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Brief Summary
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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.

Detailed Description
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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). 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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient beneficiary or affiliated to Social security system Consent signed Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy volunteers<br>Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old, | Biological: Blood samples<br>* sampling of 10 S-Monovette tubes (Sarstedt) 4.3 ml of blood specifically for the study representing a total blood volume of 43 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood, plasma, blood platelets