CHEX-DR: Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of Human Leukocyte Antigen - DR Isotype (HLA-DR) Molecules by Flow Cytometry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Patients will have one blood sampling using one EDTA tube and one Cyto-Chex BCT tube, one after the other
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patient hospitalized in intensive care unit
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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:
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Pregnant women
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Minors
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Persons deprived of their liberty by a judicial or administrative decision
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Persons subject to psychiatric care
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Adults subject to a legal protection measure (guardianship, protection of vulnerable adults)
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Patient who doesn't understand French language
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de reanimation chirurgicale | Lyon | France | 69437 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Anne-Claire LUKASZEWICZ, Professor, Hospices Civils de Lyon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL22_0446