PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

Recruiting

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

• Registration Number: NCT04842760
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-09
• Study First Posted: 2021-04-13
• Study Start: 2021-06-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Primary Completion: 2023-10
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance between ImageStream cytometer and reference laboratory tests for platelet disorders diagnosis	12 months	platelet disorders reference laboratory tests are light transmission aggregometry and serotonin release assay
Concordance between ImageStream cytometer and reference laboratory tests for HIT diagnosis	12 months	reference laboratory tests are light transmission aggregometry and serotonin release assay

Secondary Outcome Measures

Name	Time	Method
Characterization of platelet morphology with ImageStream	12 months	Analyses of data provided by the ImageStream system on platelets and platelets aggregates

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France