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

November 28, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • CHU de Saint-Etienne - Service d'Hématologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

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,

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy volunteers
Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old,
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombin generation parameter in PRP (Peak : nmol thrombin)
Time Frame: At inclusion
Peak measurement
At inclusion
Thrombin generation parameter in PRP (ETP : nmol*min)
Time Frame: At inclusion
Endogenous Thrombin Potential measurement
At inclusion
Thrombin generation parameter in PRP (LT : min)
Time Frame: At inclusion
Lag Time measurement
At inclusion
Thrombin generation parameter in PRP (V : nmol/min)
Time Frame: At inclusion
Velocity index measurement
At inclusion
Thrombin generation parameter in PRP (TTP : min)
Time Frame: At inclusion
Time to Peak measurement
At inclusion
Thrombin generation parameter in PRP (ST : min)
Time Frame: At inclusion
Start Tail measurement
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombin generation parameters in PPP (Peak : nmol thrombin)
Time Frame: At inclusion
Peak measurement
At inclusion
Thrombin generation parameters in PPP (ETP : nmol*min)
Time Frame: At inclusion
Endogenous Thrombin Potential measurement
At inclusion
Thrombin generation parameters in PPP (LT: min)
Time Frame: At inclusion
Lag Time measurement
At inclusion
Thrombin generation parameters in PPP (V : nmol/min)
Time Frame: At inclusion
Velocity index measurement
At inclusion
Thrombin generation parameters in PPP (TTP : min)
Time Frame: At inclusion
Time to Peak measurement
At inclusion
Thrombin generation parameters in PPP (ST: min)
Time Frame: At inclusion
Start Tail measurement
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Brigitte Tardy, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2021

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20CH237
  • 2021-A00293-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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