PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer (PLATELETSTREAM)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Platelet Activation; Heparin-induced Thrombocytopenia; Platelet Disorder; Platelet Aggregation

Study type: Observational

Funder types: Other

Identifiers

NCT04842760

PI2021_843_0039

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 3 patient groups

No platelet disorders or no HIT

Description:

Patients without platelet disorders or without HIT, without anti-PF4/H antibodies, without anti-aggregant treatment.

HIT patients with anti-PF4/H antibodies

Description:

patients with anti-PF4/H antibodies but for whom HIT was ruled out.

platelet dysfunction or HIT

Description:

Patients with platelet dysfunction or suffering from HIT