跳至主要内容
临床试验/NCT02510573
NCT02510573已完成不适用

Prognostic Value of Serum Ficolin-3 Levels After Severe Traumatic Brain Injury:A Pilot Study

Sanmen People's Hospital0 个研究点目标入组 128 人开始时间: 2011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
128
主要终点
Mortality after severe traumatic brain injury

研究概览

简要总结

The current study was designed to investigate the change of serum ficolin-3 levels and assess the prognostic predictive effect of serum ficolin-3 levels in the patients with severe traumatic brain injury.

详细描述

Complement activation is one of the pathological mechanisms that contribute to the secondary brain injury after traumatic brain injury. Ficolin-mediated lectin pathways of complement activation contribute to the pathogenesis of ischemic stroke and may be additive to complement-independent inflammatory processes. Lower serum ficolin-3 levels have been demonstrated to be highly associated with unfavorable outcome after ischemic stroke. This prospective observatory study was designed to investigate the relationship between serum ficolin-3 levels and 1-week mortality, 6-month mortality and 6-month unfavorable outcome (defined as Glasgow Outcome Scale score of 1-3) in patients with severe traumatic brain injury. This study recruited 128 patients and 128 sex- and age- matched healthy controls. Serum ficolin-3 levels on admission were measured by sandwich immunoassays. It was postulated that serum ficolin-3 levels were correlated with Glasgow Coma Scale scores and ficolin-3 was identified as an independent prognostic predictor for 1-week mortality, 6-month mortality and 6-month unfavorable outcome. Thus, it was proposed that lower serum ficolin-3 levels, correlated with injury severity reflected by Glasgow Outcome Scale scores, had the potential to be the useful, complementary tool to predict short- or long- term clinical outcome after severe traumatic brain injury.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Isolated head trauma
  • Postresuscitation Glasgow Coma Scale score of 8 or less.

排除标准

  • Less than 18 years of age
  • Admission time > 6 hours
  • Previous head trauma
  • Neurological disease including ischemic or hemorrhagic stroke
  • Use of antiplatelet or anticoagulant medication
  • Diabetes mellitus
  • Hypertension
  • Presence of other prior systemic diseases including uremia, liver cirrhosis, malignancy, and chronic heart or lung disease

结局指标

主要结局

Mortality after severe traumatic brain injury

时间窗: Follow-up of 6 months

Using structure telephone interviews, follow-up was performed by 1 doctor who was blinded to clinical information.

次要结局

  • Unfavorable outcome after severe traumatic brain injury(Follow-up of 6 months)

研究者

发起方
Sanmen People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiongwei Gao

Department of Neurosurgery

Sanmen People's Hospital

相似试验