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

Healthy Volunteers Clinical Trial

— NUAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842084
• Other study ID #: 20CH237
• Secondary ID: 2021-A00293-38
• Status: Completed
• Start date: April 23, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne - Service d'Hématologie	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombin generation parameter in PRP (Peak : nmol thrombin)	Peak measurement	At inclusion
Primary	Thrombin generation parameter in PRP (ETP : nmol*min)	Endogenous Thrombin Potential measurement	At inclusion
Primary	Thrombin generation parameter in PRP (LT : min)	Lag Time measurement	At inclusion
Primary	Thrombin generation parameter in PRP (V : nmol/min)	Velocity index measurement	At inclusion
Primary	Thrombin generation parameter in PRP (TTP : min)	Time to Peak measurement	At inclusion
Primary	Thrombin generation parameter in PRP (ST : min)	Start Tail measurement	At inclusion
Secondary	Thrombin generation parameters in PPP (Peak : nmol thrombin)	Peak measurement	At inclusion
Secondary	Thrombin generation parameters in PPP (ETP : nmol*min)	Endogenous Thrombin Potential measurement	At inclusion
Secondary	Thrombin generation parameters in PPP (LT: min)	Lag Time measurement	At inclusion
Secondary	Thrombin generation parameters in PPP (V : nmol/min)	Velocity index measurement	At inclusion
Secondary	Thrombin generation parameters in PPP (TTP : min)	Time to Peak measurement	At inclusion
Secondary	Thrombin generation parameters in PPP (ST: min)	Start Tail measurement	At inclusion