Prognostic Value of Serum Ficolin-3 Levels After Severe Traumatic Brain Injury:A Pilot Study
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
- 是
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
Xiongwei Gao
Department of Neurosurgery
Sanmen People's Hospital
