Clinical trial

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

Name
20CH237
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).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.
Trial arms
Trial start
2021-04-23
Estimated PCD
2023-03-30
Trial end
2023-03-30
Status
Completed
Treatment
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
Arms:
healthy volunteers
Size
75
Primary endpoint
Thrombin generation parameter in PRP (Peak : nmol thrombin)
At inclusion
Thrombin generation parameter in PRP (ETP : nmol*min)
At inclusion
Thrombin generation parameter in PRP (LT : min)
At inclusion
Thrombin generation parameter in PRP (V : nmol/min)
At inclusion
Thrombin generation parameter in PRP (TTP : min)
At inclusion
Thrombin generation parameter in PRP (ST : min)
At inclusion
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma'}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2023-12-01

1 organization

1 product

1 indication