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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 healthy adult volunteers | Other | Healthy adult volunteers without hemorrhagic diathesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Take blood (TA-8V (Stago®) | Device | Healthy volunteers will have 3 blood samples at M0, M3 and M6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelets aggregation results for LTA on TA-8V (Stago®) | Normal values for platelets aggregation will be established using various agonists to activate platelets. : • Ristocetin (STAGO®) | Month 0 |
| Platelets aggregation results for LTA on TA-8V (Stago®) | Normal values for platelets aggregation will be established using various agonists to activate platelets. :
| Month 3 |
| Platelets aggregation results for LTA on TA-8V (Stago®) | Normal values for platelets aggregation will be established using various agonists to activate platelets. :
| Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| LTA intra assay variability | Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters. | Month 0 |
| LTA intra assay variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est | Bron | 69677 | France |
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| ID | Term |
|---|---|
| D014842 | von Willebrand Diseases |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.
| Month 3 |
| LTA intra assay variability | Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters. | Month 6 |
| LTA inter operator variability | Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%). | Month 0 |
| LTA inter operator variability | Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%). | Month 3 |
| LTA inter operator variability | Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%). | Month 6 |
| Agonist reagents stability duration | 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. | 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. |
| Agonist reagents stability duration | 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. | up to 2 months post reagents reconstitution |
| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |