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

NCT ID: NCT05546632

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-13
• Study Completion Date: 2022-11-14

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Blood sampling

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Blood sampling

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Claire LUKASZEWICZ, Professor

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Service de reanimation chirurgicale

Lyon, , France

Countries

France

Other Identifiers

69HCL22_0446

Identifier Type: -

Identifier Source: org_study_id