Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of Human Leukocyte Antigen - DR Isotype (HLA-DR) Molecules by Flow Cytometry (CHEX-DR)

Civil Hospices of Lyon

Status: Completed

Conditions: Critical Care

Treatments: Diagnostic Test: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT05546632

69HCL22_0446

Details and patient eligibility

About

The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Nevertheless, pre-analytical constraints (storage of samples at +4°C before analysis) limit the wide use of mHLA-DR in clinical practice (problem of transporting samples to sites with a flow cytometer). Recent studies have shown that samples taken on Cyto-Chex Blood Collection Tubes (BCT) (containing a cell membrane stabilizer) were, for mHLA-DR, stable at room temperature during 72 hours after sampling. The main objective of this study is to compare the expression of mHLA-DR from samples taken simultaneously from standard tubes (EDTA) and new generation Cyto-Chex BCT tubes, to validate using Cyto Chex BCT tube in the clinical practice.

The investigators think that mHLA-DR quantification performed from Cyto-Chex BCT tubes is reliable and similar to quantification performed from EDTA tubes.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient hospitalized in intensive care unit
• Patient able to consent and having expressed his non-objection (in the case where the patient is aware) OR Patient whose trusted person has given his non-objection (in the case where the patient is not able to consent, example intubated patient)

Exclusion criteria

• Pregnant women
• Minors
• Persons deprived of their liberty by a judicial or administrative decision
• Persons subject to psychiatric care
• Adults subject to a legal protection measure (guardianship, protection of vulnerable adults)
• Patient who doesn't understand French language

Trial design

40 participants in 1 patient group

Critically ill patients

Description:

Patients included in this study will have blood sampling using EDTA tube and nex generation Cyto-Chex BCT tubes in order to compare compare the expression of mHLA-DR with these two types of tubes

Treatment:

Diagnostic Test: Blood sampling