PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

NCT ID: NCT04842760

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-11-30

Brief Summary

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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

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Conditions

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Platelet Disorder Heparin-induced Thrombocytopenia Platelet Activation Platelet Aggregation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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No platelet disorders or no HIT

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

No interventions assigned to this group

HIT patients with anti-PF4/H antibodies

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

No interventions assigned to this group

platelet dysfunction or HIT

Patients with platelet dysfunction or suffering from HIT

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Maïlys LE GUYADER, MD

Role: CONTACT

03.22.08.70.00

Facility Contacts

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Maïlys LE GUYADER, MD

Role: primary

03.22.08.70.00

Other Identifiers

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PI2021_843_0039

Identifier Type: -

Identifier Source: org_study_id

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