Clinical Trial

Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

Study acronym: FLAMES
Not Yet Recruiting
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.
Trial Details
NCT Number NCT07585942
Lead Sponsor University Hospital, Strasbourg, France
Conditions Sepsis, Disseminated Intravascular Coagulation (DIC), Septic Shock
Enrollment 492 participants
Start Date 2026-05-12
Primary Completion 2027-11-12 (estimated)
Study Completion 2027-12-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-14