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临床试验/NCT07585942
NCT07585942尚未招募不适用

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

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 492 人开始时间: 2026年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
492
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Admission to the ED
  • Suspected or proven infection defined by the prescription of antibiotic therapy within 24 hours following admission to the ED
  • Collection of an EDTA blood sample as part of routine care
  • Patient informed and has not expressed opposition

排除标准

  • Pregnancy or breastfeeding
  • Legal protection measure (guardianship, curatorship, judicial protection)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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