PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

Study Overview
=================
Brief Summary
-----------------
Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia [HIT]) troubles. Diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. These platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. The investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the ImageStream cytometer. The use of this cytometer offers an innovative approach. This study is a monocentric prospective and non-interventional study. The investigators will analyze patient samples with the ImageStream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. This new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.

Official Title
-----------------
PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

Conditions
-----------------
Platelet Disorder, Heparin-induced Thrombocytopenia, Platelet Activation, Platelet Aggregation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT Exclusion Criteria: minor patients patients who have opposed the use of their personal data for research work.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No platelet disorders or no HIT<br>Patients without platelet disorders or without HIT, without anti-PF4/H antibodies, without anti-aggregant treatment. | |
| HIT patients with anti-PF4/H antibodies<br>patients with anti-PF4/H antibodies but for whom HIT was ruled out. | |
| platelet dysfunction or HIT<br>Patients with platelet dysfunction or suffering from HIT | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between ImageStream cytometer and reference laboratory tests for platelet disorders diagnosis | platelet disorders reference laboratory tests are light transmission aggregometry and serotonin release assay | 12 months | 
| Concordance between ImageStream cytometer and reference laboratory tests for HIT diagnosis | reference laboratory tests are light transmission aggregometry and serotonin release assay | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of platelet morphology with ImageStream | Analyses of data provided by the ImageStream system on platelets and platelets aggregates | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet Disorder, Heparin-induced Thrombocytopenia, ImageStream cytometer, Platelet activation, Platelet aggregation