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| ID | Type | Description | Link |
|---|---|---|---|
| CE-2026-37 | Other Identifier | ETHICS COMMITTEE of the Faculties of Medicine, Dentistry, Pharmacy, Nursing Schools, Physiotherapy, Midwifery, and Hosp |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | The primary evaluation criterion is the occurrence of sepsis or septic shock within 72 hours following admission to the Emergency Department, defined according to SEPSIS-3 by at least one of the following:
| 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted to the Emergency Department and undergoing routine blood sampling will be prospectively included. The cohort aims to evaluate early biomarkers for the prediction of sepsis or septic shock within 72 hours of admission. No additional procedures or interventions beyond standard care are performed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie HELMS, Professor | Contact | +33 3 69 55 13 69 | julie.helms@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Hospitals of Strasbourg, Intensive Care Medicine Department - New Civil Hospital | Strasbourg | 67098 | France |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004211 | Disseminated Intravascular Coagulation |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D019851 | Thrombophilia |
| D012769 | Shock |