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

Completed

• Conditions: Critical Care
• Interventions: Diagnostic Test: Blood sampling

• Registration Number: NCT05546632
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-21
• Study Start: 2022-10-13
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients	Blood sampling	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

Primary Outcome Measures

Name	Time	Method
Quantity of anti-HLA-DR antibodies per cell	The day of inclusion	The quantity of anti-HLA-DR antibodies per single cell will be assessed in each tube (EDTA and Cyto Chex) using flowcytometry

Trial Locations

Locations (1)

Service de reanimation chirurgicale; 🇫🇷 Lyon, France