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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    65
  • sponsor
    University Hospital, Clermont-Ferrand
Updated on 15 October 2022

Summary

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.

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.

Details
Condition Patients Without a Medical History of Thrombosis or Hemorrhage, Hemophilic Patient, Patient With FV Leiden Mutation, Patient With Cirrhosis, Patient on Anticoagulant
Clinical Study IdentifierNCT05422157
SponsorUniversity Hospital, Clermont-Ferrand
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

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%
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
patients with Child-Pugh B
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
patients on apixaban for at least 1 week
patients on rivaroxaban for at least 1 week
patients on dabigatran for at least 1 week
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note