PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04842760

Acronym

PLATELETSTREAM

Enrollment

Registered

2021-04-13

Start date

2021-03-01

Completion date

2021-10-15

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Platelet Disorder, Heparin-induced Thrombocytopenia, ImageStream cytometer, Platelet activation, Platelet aggregation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results