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

NCT ID: NCT04842084

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-23

Study Completion Date

2023-03-30

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Keywords

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blood plasma blood platelets

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy volunteers

Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old,

Blood samples

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brigitte Tardy, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de Saint-Etienne - Service d'Hématologie

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00293-38

Identifier Type: OTHER

Identifier Source: secondary_id

20CH237

Identifier Type: -

Identifier Source: org_study_id