NCT01688869已完成不适用
Mild Traumatic Brain Injury Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.
研究概览
简要总结
The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.
详细描述
The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a negative CT scan. The investigators will be collecting blood samples, and administering cognitive and balance tests. The investigators will also be following symptoms and cognition throughout the first year to help define typical recovery, and guide prognosis.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have defined history of CHI (closed head injury) which produced an altered state of consciousness or mood
- •Must be awake and alert (Glasgow Coma Scale 13-15)
- •Must be enrolled within 72 hours of injury
- •Must have CT or MRI neuroimaging performed
排除标准
- •Diabetes Mellitus with severe complications
- •Intoxication at time of enrollment
- •Major psychiatric disorder that is poorly controlled
- •Prior stroke
- •History of Social Security defined "disability
- •Uncontrolled Seizure Disorder
- •Incarceration or arrest
- •Concurrent Injury requiring hospitalization
- •Use of anticoagulant drugs
- •Any condition the investigator deems as inappropriate for patient enrollment
- •Personality disorder
- •Heart, liver or kidney failure defined using common clinical practice guidelines
- •Baseline cognitive impairment
- •Homelessness
- •TBI associated with interpersonal violence
- •Pregnancy
- •Long bone fracture requiring surgical stabilization
结局指标
主要结局
To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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