Healthy Volunteer
Conditions
Keywords
light transmission aggregometry, platelets, platelet functions, von Willebrand disease, quality assessment
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.
Interventions
DEVICETake blood (TA-8V (Stago®)
Healthy volunteers will have 3 blood samples at M0, M3 and M6.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female adults aged between 18 and 70 years * Weighting more than 50 kg * Subjects having signed informed consent * Subjects registered in the French health-care system database
Exclusion criteria
* Personal history of anemia, thrombopenia, hemorrhagic disease * Caffeine intake 2 hours prior to blood sampling * Tobacco intake in the half hour prior to blood sampling * Use of any drug impacting platelet function * for antiplatelet agents: at least 10 days prior to blood sampling * for anti-depressants: at least 10 days prior to blood sampling * for non-steroid anti-inflammatories: at least 3 days prior to blood sampling * Refusal to undergo the 3 visits and 3 blood samples of the study * Refusal to sign the informed consent form * No registration in the French Health-care system database * Pregnant women and women who are breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelets aggregation results for LTA on TA-8V (Stago®) | Month 0 | Normal values for platelets aggregation will be established using various agonists to activate platelets. : • Ristocetin (STAGO®) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LTA intra assay variability | Month 0 | Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters. |
| LTA inter operator variability | Month 0 | Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%). |
| Agonist reagents stability duration | up to 2 months post reagents reconstitution and 2 months post reconstitution with the same technician, the same automaton and the same healthy volunteer sample. | Reagents will be reconstituted and stored at -20°C. They will be used for aggregation assay extemporaneously, 1 week, 2 weeks , 1 month and 2 months post reconstitution. |
Countries
France
Outcome results
None listed