Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-20 @ 12:31 PM
Study NCT ID:
NCT05422157
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2022-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Genesia System
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Genesia System
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVIGE
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A01971-40 | OTHER | 2021-A01971-40 | View |