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临床试验/NCT06314841
NCT06314841终止不适用

Polytrauma and Resuscitation Impact on Innate Immunity

Ludwig Boltzmann Gesellschaft3 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
62
试验地点
3
主要终点
Immunocompetence

研究概览

简要总结

Major trauma can lead to a dysregulated response to secondary infection. Severe injuries are accompanied by pro- and antiinflammatory changes that affect both adaptive and innate immunity. In this study we aim to assess cellular immuno-competence early during treatment in an attempt to identify signs of immuno-suppression.

详细描述

Polytrauma represents one of the most challenging critical conditions for caretakers worldwide and involves multiple damages of different anatomical regions. Severe traumatic injuries are among the primary causes of death among young people under the age of 45 and half of them are due to uncontrollable bleeding. In the acute injury phase of trauma, severe blood loss is often accompanied by biochemical, cellular and physiological dysfunctions leading to an inflammatory response, infections and in some cases coagulopathy. We aim to identify immuno-suppression by analyzing phagocytic capacity, leukocyte subsets, surface molecule expression and extracellular vesicles in the peripheral blood of severly injured patients.

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
  • Injury Severity Score (ISS) > 15
  • Incident to admission time < 3h

排除标准

  • Preexisting condition
  • Pregnancy or breastfeeding
  • Coronary Heart Disease
  • Intake of antiphlogistic medication

结局指标

主要结局

Immunocompetence

时间窗: 30 days after admission to ER

Infection during observation period

次要结局

  • Changes in cellular immuno-status(0 hours, 24 hours, 48 hours, 96 hours after admission to ER)
  • Release of extracellular vesicles and associated content(0 hours, 24 hours after admission to ER)
  • Platelet-leukocyte aggregates(0 hours, 24 hours after admission to ER)
  • Immunocompetence clusters(30 days after admission to ER)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerhard Fritsch

Priv.-Doz., Prim., Dr.med.univ

Ludwig Boltzmann Gesellschaft

研究点 (3)

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