NCT04842084

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

April 23, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

April 8, 2021

Last Update Submit

November 28, 2023

Conditions

Healthy Volunteers

Keywords

bloodplasmablood platelets

Outcome Measures

Primary Outcomes (6)

  • Thrombin generation parameter in PRP (Peak : nmol thrombin)

    Peak measurement

    At inclusion

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

    Endogenous Thrombin Potential measurement

    At inclusion

  • Thrombin generation parameter in PRP (LT : min)

    Lag Time measurement

    At inclusion

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

    Velocity index measurement

    At inclusion

  • Thrombin generation parameter in PRP (TTP : min)

    Time to Peak measurement

    At inclusion

  • Thrombin generation parameter in PRP (ST : min)

    Start Tail measurement

    At inclusion

Secondary Outcomes (6)

  • Thrombin generation parameters in PPP (Peak : nmol thrombin)

    At inclusion

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

    At inclusion

  • Thrombin generation parameters in PPP (LT: min)

    At inclusion

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

    At inclusion

  • Thrombin generation parameters in PPP (TTP : min)

    At inclusion

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Blood samplesBIOLOGICAL

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

healthy volunteers

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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,

You may qualify if:

  • Patient beneficiary or affiliated to Social security system
  • Consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne - Service d'Hématologie

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Brigitte Tardy, MD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 13, 2021

Study Start

April 23, 2021

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)