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临床试验/NCT01713205
NCT01713205Unknown不适用

Identifying Severe Trauma Patients at High Risk of Post-traumatic Complications

Jiang Jianxin6 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,500
试验地点
6
主要终点
morbidity rate of complications after trauma (including sepsis and MODS)

研究概览

简要总结

The purpose of this study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample of severe trauma patients.

详细描述

Trauma is a major public health problem worldwide, ranking as the fourth leading cause of death. One of the most serious complications of major trauma is sepsis, which often induces sequential multiple organ dysfunction syndrome (MODS). There were still no specific biomarkers to predict the susceptibility of complications and outcomes, which leading to the limited prevention methods and the high mortality rate of severe trauma patients. Previous studies from our and other group have found some sepsis and MODS predictors, including genetic polymorphisms, serum cytokines and cell-surface markers. The purposes of this multi-center observational study is to select biomarkers and evaluate a clinically and economically most effective diagnostic algorithm for prediction of complications in severe trauma 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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age> 16 years old and <65 years old
  • severe trauma patients (AIS ≧3 or ISS≧16)
  • admission within 48 hours after injury
  • given and signed informed consent

排除标准

  • died within 48h after injury
  • being pregnant or lactating
  • chronic organ dysfunction comorbidities
  • long-term anticoagulant therapy before injury
  • presence of immunosuppression before injury

结局指标

主要结局

morbidity rate of complications after trauma (including sepsis and MODS)

时间窗: patients will be followed for the duration of hospital stay, an expected average of 3 weeks

次要结局

  • survival(witnin 30 days and 60 days after injury)

研究者

发起方
Jiang Jianxin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jiang Jianxin

Principal Investigator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

研究点 (6)

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