Skip to main content
OpenTrials
Completed

NCT Number: NCT04842760

PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Concordance between ImageStream cytometer and reference laboratory tests for platelet disorders diagnosis

    Time frame: 12 months

    platelet disorders reference laboratory tests are light transmission aggregometry and serotonin release assay

  2. Concordance between ImageStream cytometer and reference laboratory tests for HIT diagnosis

    Time frame: 12 months

    reference laboratory tests are light transmission aggregometry and serotonin release assay

Secondary outcomes

  1. Characterization of platelet morphology with ImageStream

    Time frame: 12 months

    Analyses of data provided by the ImageStream system on platelets and platelets aggregates

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PLATELETSTREAM

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.