NCT07630415尚未招募不适用
OPTIMIZATION AND CLINICAL VALIDATION OF AN INNOVATIVE TEST FOR THE EARLY DIAGNOSIS OF SEPTIC DIC VIA AN AUTOMATION INTEGRATING ARTIFICIAL INTELLIGENCE
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6月15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
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.
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
- 否
入选标准
- •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.
排除标准
- •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
研究者
研究点 (1)
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