Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Ge… (NCT05422157) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Genesia System
France71 participantsStarted 2022-09-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the inter-center analytical variability of the thrombin generation measurement on ST Genesia, on different types of normo-, hypo- or hyper-coagulable samples.