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CompletedNCT04269603

LTA Assessement Using Aggregometer TA-8V (Stago®)

Normal Values and Quality Assessment of Light Transmission Aggregometry (LTA) Using Aggregometer TA-8V (Stago®)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICETake blood (TA-8V (Stago®)Healthy volunteers will have 3 blood samples at M0, M3 and M6.

Timeline

Start date
2020-11-03
Primary completion
2021-01-06
Completion
2021-01-06
First posted
2020-02-17
Last updated
2022-02-14

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04269603. Inclusion in this directory is not an endorsement.

LTA Assessement Using Aggregometer TA-8V (Stago®) (NCT04269603) · Clinical Trials Directory