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NCT Number: NCT04842084

Normal Values of Parameters of Thrombin Generation 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne - Service d'Hématologie

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples

Biological

sampling of 10 S-Monovette tubes (Sarstedt) 4.3 ml of blood specifically for the study representing a total blood volume of 43 ml

Primary outcomes

  1. Thrombin generation parameter in PRP (Peak : nmol thrombin)

    Time frame: At inclusion

    Peak measurement

  2. Thrombin generation parameter in PRP (ETP : nmol*min)

    Time frame: At inclusion

    Endogenous Thrombin Potential measurement

  3. Thrombin generation parameter in PRP (LT : min)

    Time frame: At inclusion

    Lag Time measurement

  4. Thrombin generation parameter in PRP (V : nmol/min)

    Time frame: At inclusion

    Velocity index measurement

  5. Thrombin generation parameter in PRP (TTP : min)

    Time frame: At inclusion

    Time to Peak measurement

  6. Thrombin generation parameter in PRP (ST : min)

    Time frame: At inclusion

    Start Tail measurement

Secondary outcomes

  1. Thrombin generation parameters in PPP (Peak : nmol thrombin)

    Time frame: At inclusion

    Peak measurement

  2. Thrombin generation parameters in PPP (ETP : nmol*min)

    Time frame: At inclusion

    Endogenous Thrombin Potential measurement

  3. Thrombin generation parameters in PPP (LT: min)

    Time frame: At inclusion

    Lag Time measurement

  4. Thrombin generation parameters in PPP (V : nmol/min)

    Time frame: At inclusion

    Velocity index measurement

  5. Thrombin generation parameters in PPP (TTP : min)

    Time frame: At inclusion

    Time to Peak measurement

  6. Thrombin generation parameters in PPP (ST: min)

    Time frame: At inclusion

    Start Tail measurement

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: NUAGE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2021
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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