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

Critical Care Clinical Trial

— CHEX-DR  

Official title:

Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of HLA-DR Molecules by Flow Cytometry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546632
• Other study ID #: 69HCL22_0446
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: November 13, 2022

Study information

• Verified date: September 2022
• Source: Hospices Civils de Lyon
• Contact: Anne-Claire LUKASZEWICZ, Professor
• Phone: + 33 (4 )72 11 13 27
• Email: Anne-claire.lukaszewicz[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 13, 2022
• Est. primary completion date: November 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care

Intervention

Diagnostic Test:
• Blood sampling
Patients will have one blood sampling using one EDTA tube and one Cyto-Chex BCT tube, one after the other

Locations

Country	Name	City	State
France	Service de reanimation chirurgicale	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of anti-HLA-DR antibodies per cell	The quantity of anti-HLA-DR antibodies per single cell will be assessed in each tube (EDTA and Cyto Chex) using flowcytometry	The day of inclusion