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

NCT05546632 | Completed

• 1 other identifier: 69HCL22_0446
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Care

Keywords

Intensive care unit; HLA-DR; blood sample; Cyto-chex tube; EDTA tube

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Critically ill patients

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

Diagnostic Test: Blood sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

Patients will have one blood sampling using one EDTA tube and one Cyto-Chex BCT tube, one after the other

Critically ill patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will focus on patients hospitalized in the intensive care unit of the Edouard Herriot hospital in Lyon

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de reanimation chirurgicale

Lyon, 69437, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anne-Claire LUKASZEWICZ, Professor

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: October 13, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)