Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-04 @ 8:14 PM
Study NCT ID:
NCT04269603
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2019-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LTA Assessement Using Aggregometer TA-8V (Stago®)
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Normal Values and Quality Assessment of Light Transmission Aggregometry (LTA) Using Aggregometer TA-8V (Stago®)
Status:
COMPLETED
Status Verified Date:
2022-01
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:
NORMAGREG
Brief Summary:
Exploring platelet functions requires aggregation tests platelet. The Haematology Laboratory of Hospices Civils de Lyon currently has two new TA-8V plate aggregation automatons® (Stago).
The supplier of these devices does not offer reference values for these tests. There are also no references in the data literature. Therefore reference values must be established from healthy volunteer subjects.
The use of these automatons is subject to the NF (French Standard) EN (European Standard) ISO (International Organization for Standardization) 15189 standard of the COFRAC ( French Accreditation Comity) that requires checking their proper functioning. This audit must be traced in a method validation folder.
The supplier of these devices does not offer reference values for these tests. There are also no references in the data literature. Therefore reference values must be established from healthy volunteer subjects.
The use of these automatons is subject to the NF (French Standard) EN (European Standard) ISO (International Organization for Standardization) 15189 standard of the COFRAC ( French Accreditation Comity) that requires checking their proper functioning. This audit must be traced in a method validation folder.
Detailed Description:
None
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?: