PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

NCT04842760 | Unknown

• 1 other identifier: PI2021_843_0039
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Characterization of platelet morphology with ImageStream

  12 months

Study Arms (3)

No platelet disorders or no HIT

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

HIT patients with anti-PF4/H antibodies

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

platelet dysfunction or HIT

Patients with platelet dysfunction or suffering from HIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT.

You may qualify if:

• male or female patient for whom a blood test was prescribed in a context of diagnosis of platelet dysfunction or HIT

You may not qualify if:

• minor patients
• patients who have opposed the use of their personal data for research work.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Blood Platelet Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Maïlys LE GUYADER, MD

CONTACT

03.22.08.70.00; leguyader.mailys@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 13, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)