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NCT04842760 Clinical Trial

PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

Heparin-induced Thrombocytopenia Clinical Trial

— PLATELETSTREAM  

Official title:
PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04842760
Other study ID # PI2021_843_0039
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date November 2023

Study information
Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Maïlys LE GUYADER, MD
Phone 03.22.08.70.00
Email leguyader.mailys@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date November 2023
Est. primary completion date October 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Characterization of platelet morphology with ImageStream Analyses of data provided by the ImageStream system on platelets and platelets aggregates 12 months
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