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Completed

NCT Number: NCT05546632

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

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.

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Key information

Conditions

Critical Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de reanimation chirurgicale

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Diagnostic Test

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

Primary outcomes

  1. Quantity of anti-HLA-DR antibodies per cell

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: CHEX-DR

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2022
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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