Fluorescent Leukocytes as a Marker of Early Sepsis/Severity

Sponsor
University Hospital, Strasbourg, France
Study ID
NCT07585942
Status
Not Yet Recruiting

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Conditions

  • Disseminated Intravascular Coagulation (DIC)
  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 14, 2026
Start date
May 12, 2026
Status verified
May 2026
Primary completion
Nov 12, 2027
Completion
Dec 12, 2027

Study Design

Enrollment
492 participants (estimated)

Arms

  • Arm: Emergency Patients
    Prospective multicenter observational cohort study evaluating the prognostic value of neutrophil fluorescence parameters measured at emergency department admission using a novel hematology analyzer. Data are collected from routine blood samples and used to develop an artificial intelligence model without additional intervention.

Primary Outcome Measure

Evaluate the association between neutrophil fluorescence, whether isolated or integrated into an AI model based on CBC results combined with the advanced multiparametric capabilities of the SthemA 801 analyzer [ Time Frame: 3 days ]

Central Contacts

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