Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Genesia System (EVIGE)

July 11, 2024 updated by: University Hospital, Clermont-Ferrand

The thrombin generation test is a global test for the study of coagulation that allows the fine study of the balance between procoagulant and anticoagulant factors. For many years, it has been performed in laboratories by semi-automated techniques, sometimes using in-house reagents, which led to a high variability and did not allow multicenter studies. Recently, an automated device for the evaluation of thrombin generation has been placed on the market (ST-Genesia), allowing a better standardization of the technique. In order to allow multicenter studies, which are essential for the routine positioning of the thrombin generation test, the inter-center variability must be evaluated, as a priority, in the pathologies for which the test is routinely positioned.

Thrombin generation (TG) assays are long-established research tools in hemostasis. They are used for both fundamental and clinical research, but a multiplicity of test methodologies limits the large adoption of TG due to the variability of results despite the attempts to standardize practices.

Several publications already exist to evaluate its analytical performances, and thereby demonstrate that the test automation also allows its democratization to reach acceptable performances It also enables the evaluation of the device in various indications such as, for example, the evaluation of the effect of direct oral anticoagulants or the evaluation of the risk of breast cancer recurrence.

The confirmation of these anterior results allows further clinical investigations in larger cohorts. However, the absence of interchangeability between the two systems indicates that the results will need to be more rugged through multicenter studies on ST Genesia.

Study Overview

Status

Completed

Conditions

Detailed Description

A preliminary step in the development of multi-center protocols is to confirm that inter-center variability is acceptable on ST Genesia, and even more acceptable than it was on Calibrated Automated Thrombogram (CAT). Since the variability of the results can be attributed to analytical, pre-analytical and inter-individual biological variabilities, it has been agreed that the evaluation that we will conduct will focus only on the analytical variability and will therefore be carried out on the same samples, collected and prepared in the sponsoring center of the study, and distributed in the form of frozen aliquots to the different co-investigating centers.

The evaluation of this inter-center variability of this new device will allow, if satisfactory, to propose multicenter studies. These are essential in order to position the thrombin generation test in routine in these various promising clinical contexts.

Study Type

Observational

Enrollment (Actual)

71

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
      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient taken care of at the Clermont-Ferrand University Hospital

Description

Inclusion Criteria:

  • Major patient, male or female
  • Affiliated to a social security system
  • In capacity to express informed consent to participate in research
  • Control group: 5 men, 5 women without oral contraception, 5 women with oral contraception and apparently healthy with a respect to hemostasis (no history of thrombosis or significant bleeding on examination)
  • Hemophilia groups: - 5 hemophiliacs A (treated or untreated), with predictable FVIII:C levels between < 1% and 40%.
  • 5 hemophiliacs B (treated or not), with predictable FIX:C levels between < 1% and 40%.
  • FV Leiden group: 5 patients known to be heterozygous or homozygous for the R506Q mutation of the F5 gene (the so-called "Factor V Leiden" mutation)
  • Cirrhosis group: - 5 patients with Child-Pugh A
  • 5 patients with Child-Pugh B
  • 5 patients with Child-Pugh C
  • Anticoagulation group: - 5 patients on anti-vitamin K therapy for at least 1 month, with INR between 2 and 4
  • 5 patients on apixaban for at least 1 week
  • 5 patients on rivaroxaban for at least 1 week
  • 5 patients on dabigatran for at least 1 week
  • 5 patients on low molecular weight heparin for at least 1 day

Exclusion Criteria:

  • Refusal to participate
  • Patient under protective measures (guardianship, curatorship) or under judicial protection
  • Minor patients
  • Moderate to end-stage renal failure
  • Proven inflammatory state/infectious syndrome (body temperature > 38°C and/or clinical signs suggestive of infection) during or in the week prior to collection, at the discretion of the investigator
  • Transfusion in the week prior to collection
  • Pregnant or breastfeeding woman
  • Contraception by estrogen-progestin, except for the control group concerned
  • Anticoagulation of less than one week, except for the anticoagulation group
  • Control group: - Presence of drug treatment known to interfere with hemostasis
  • Presence of a pathology known to interfere with hemostasis such as renal or hepatic insufficiency
  • Presence of a history of venous thromboembolic disease or diagnosed hemorrhagic disease
  • Predicted inclusion hemoglobin level < 7g/L
  • Hemophilic groups: - Presence of anti FVIII or anti FIX inhibitors
  • Treatment with emicizumab
  • Predicted inclusion hemoglobin level < 7g/L
  • FV Leiden group: - Presence of anticoagulant therapy at the time of collection
  • Predicted baseline hemoglobin < 7g/L
  • Anticoagulation group: - Anticoagulant therapy not stabilized as determined by the practitioner
  • Presence of a therapeutic relaunch in progress
  • Hemoglobin at predicted inclusion < 9-10g/L
  • Cirrhosis group: Predicted inclusion hemoglobin level < 7g/L

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

Cohorts and Interventions

Group / Cohort
Control
No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care.
Hemophilia
No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care.
FV Leiden
No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care.
Cirrhosis
No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care.
Anticoagulation
No intervention. Collection of additional blood volume (50 mL) during blood tests provided as part of the usual medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the inter-center analytical variability of the thrombin generation measurement on ST Genesia, on different types of normo-, hypo- or hyper-coagulable samples.
Time Frame: at the time of inclusion
Assessing the analytical variability of the thrombin generation measurement on ST Genesia, compared to that observed on CAT, on different groups of patients
at the time of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of inter-center analytical variability on ST Genesia related to different reagent lots, for centers with multiple reagent lots.
Time Frame: at the time of inclusion
Measure of the thrombin generation in absolute value
at the time of inclusion
Comparing the analytical variability between centers observed on the same samples on the reference system, the Calibrated Automated Thrombogram, for centers also equipped with this device
Time Frame: at the time of inclusion
Investigate the differences between thrombin generation measurements on CAT and ST genesia
at the time of inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Diagnostica Stago

Investigators

  • Principal Investigator: Aurélien LEBRETON, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 7, 2022

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2021 LEBRETON 3 (EVIGE)
  • 2021-A01971-40 (Other Identifier: 2021-A01971-40)

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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