Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Biomarker profiles
研究概览
简要总结
The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.
详细描述
The collected samples will be alienated to the Sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The laboratories will analyze the samples blinded, without knowing whether the sample was from an injured patient or a healthy control.
入排标准
- 年龄范围
- 1 Minute 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is suspected of having an isolated mild TBI (Glasgow Coma Score 13 - 15)
- •No more that 6 hours elapsed from the incident of injury at the first sampling
- •The patient is conscious
- •Informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures
排除标准
- •More than 6 hours elapsed from the injury, or unknown time of trauma
- •Multi-trauma patient
- •History of head injury, seizures or stroke within three preceding months
- •Chronic neurodegenerative, metabolic or autoimmune disease
- •Known existing neurological condition
结局指标
主要结局
Biomarker profiles
时间窗: 12 months
Characterization of different glycan structures present in the sample by mass spectrometry analysis
Biomarker levels
时间窗: 12 months
Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay
次要结局
未报告次要终点