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NOT YET RECRUITING
NCT07585942

Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

Summary

Sepsis is a medical emergency whose prognosis depends on the early identification of patients at risk of septic shock, but the tools available in the Emergency Department remain insufficient. Neutrophils, key players in immunothrombosis, show alterations detectable via cell fluorescence (e.g., NE-SFL), which are strongly correlated with the severity of sepsis and septic DIC. The FLAMES study will evaluate, from the time of admission to the Emergency Department, the relevance of neutrophil fluorescence as an early biomarker of severity, either alone or integrated into an AI model based on the multiparametric data from the SthemA 801, with comparison to the Sysmex XN. It aims to address an unmet clinical need: the immediate stratification of the risk of severe forms of sepsis. Hypothesis: higher initial fluorescence will identify patients at risk of organ failure, septic shock, or DIC.

Official title: NEUTROPHIL FLUORESCENCE AS AN EARLY BIOMARKER OF SEPSIS SEVERITY IN THE EMERGENCY DEPARTMENT

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

492

Start Date

2026-05-12

Completion Date

2027-12-12

Last Updated

2026-05-14

Healthy Volunteers

No

Locations (1)

The University Hospitals of Strasbourg, Intensive Care Medicine Department - New Civil Hospital

Strasbourg, France