Clinical trial NCT04842084: Normal Values of Parameters of Thrombin Generation in Function of Different Tissue Factor Concentrations
Official title: Determination of Normal Values of Parameters of Thrombin Generation in Fresh PRP and in PPP in Function of Different Tissue Factor Concentrations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: blood
plasma
blood platelets
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old,

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Thrombin generation parameter in PRP (Peak : nmol thrombin)
timeFrame: At inclusion
measure: Thrombin generation parameter in PRP (ETP : nmol*min)
timeFrame: At inclusion
measure: Thrombin generation parameter in PRP (LT : min)
timeFrame: At inclusion
measure: Thrombin generation parameter in PRP (V : nmol/min)
timeFrame: At inclusion
measure: Thrombin generation parameter in PRP (TTP : min)
timeFrame: At inclusion
measure: Thrombin generation parameter in PRP (ST : min)
timeFrame: At inclusion
Secondary outcomes:
measure: Thrombin generation parameters in PPP (Peak : nmol thrombin)
timeFrame: At inclusion
measure: Thrombin generation parameters in PPP (ETP : nmol*min)
timeFrame: At inclusion
measure: Thrombin generation parameters in PPP (LT: min)
timeFrame: At inclusion
measure: Thrombin generation parameters in PPP (V : nmol/min)
timeFrame: At inclusion
measure: Thrombin generation parameters in PPP (TTP : min)
timeFrame: At inclusion
measure: Thrombin generation parameters in PPP (ST: min)
timeFrame: At inclusion
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne - Service d'Hématologie
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Brigitte Tardy, MD
role: PRINCIPAL_INVESTIGATOR
References: