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临床试验/NCT00710411
NCT00710411已完成不适用

Inflammatory Response in Polytraumatized Patients

University of Ulm1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes

研究概览

简要总结

The purpose of this study is to determine the inflammatory response after multiple trauma in humans.

详细描述

Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for an uneventful outcome in the posttraumatic phase. One of the main functions of the inflammatory response is the recognition and elimination of damaged tissues and microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It remains unclear whether, when and how an interplay of complement system, NF-kB, danger and pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be beneficial and harmful. Differing activation of the complement system, pro-inflammatory biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead to varying outcome. Therefore, this prospective observational study will enroll n=60 polytraumatized patients with an ISS>18 to monitor longitudinally their inflammatory response after trauma and to find out whether there is a discriminating pattern of the cross talk between complement system, biomarkers and apoptosis in patients with beneficial or harmful outcome.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • multiple trauma injury, injury severity score (ISS) > 18 with
  • isolated fractures of the extremities
  • fractures of the extremities combined with blunt/penetrating visceral trauma
  • fractures of the extremities combined with blunt/penetrating thoracic trauma
  • isolated head injury with morphological changes in CCT
  • combination of points 1 - 4

排除标准

  • life expectancy < 24 hours
  • participation in other trials
  • ISS < 18
  • cardiopulmonary reanimation on the accident scene or dying immediately after hospital admission
  • age < 18 years
  • known or suspected pregnancy
  • patients with ray-treatment or chemotherapy within the last three months

结局指标

主要结局

Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes

时间窗: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma

次要结局

  • inflammatory biomarkers, cell surface markers, apoptosis, functional polymorphisms, mesenchymal stem cells, severity of injury (ISS), infections, SIRS, sepsis, shock, organ dysfunctions, severity of disease, ICU length of stay, wound healing, mortality(0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma for biochemical and immunological parameters; ISS on admission; scores on a daily basis; ICU and hospital death on discharge)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manfred Weiss

Professor, MD, MBA

University of Ulm

研究点 (1)

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