Disseminated Intravascular Coagulation is a severe complication of septic shock, associated with high mortality, whose diagnosis relies on complex scores that are rarely used in practice. Preliminary studies have shown that increased neutrophil fluorescence is associated with Disseminated Intravascular Coagulation and could reflect NETosis, a key mechanism of immunothrombosis. This study aims to validate neutrophil fluorescence measured on the SthemA 801 analyzer, alone or integrated into an artificial intelligence model, as an early, reliable, and routinely usable biomarker for the diagnosis of septic Disseminated Intravascular Coagulation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male or female ≥ 18 years old
* Patient admitted to intensive care for septic shock
* Patient affiliated with a social security scheme or having rights
* No objection from the patient or a relative in case the patient is not able to express consent, or inclusion under emergency procedure in case the patient is not able to express their opinion and no relative of the patient is reachable.
Exclusion Criteria:
* Moribund patient on the day of inclusion
* Child-Pugh C cirrhosis
* Neutropenia (\<500 mm3)
* Patient under legal protection
* Patient under guardianship or curatorship
* Pregnancy/ Breastfeeding
Primary outcome measure(s)
Early diagnosis of disseminated intravascular coagulation in patients with septic shock hospitalized in medical intensive care using the neutrophil fluorescence ratio or an AI model based on complete blood count results — From admission to intensive care until day 2 after admission 1. Development and validation of the optimal neutrophil fluorescence threshold/ratio on the sthemA 801 analyzer for the early diagnosis of septic DIC in patients with septic shock admitted to medical intensive care.
2. Development and validation of the AI model, based on the results of the CBC combined with the advanced multiparametric capabilities of the sthemA 801 analyzer, for the early diagnosis of septic DIC in patients with septic shock admitted to medical intensive care.
Trial sites (1)
Facility
City
Region
Status
The University Hospitals of Strasbourg, Intensive Care Medicine Department - New Civil Hospital
Strasbourg
France
More University Hospital, Strasbourg, France trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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