NCT05725993招募中不适用
Longitudinal Assessment of Traumatic Microvascular Injury-2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Brain Atrophy
研究概览
简要总结
The goal of this observational study is to learn about changes in the brain of patients over the first 3 years following a traumatic brain injury (TBI). The main question it aims to answer are:
- How TBI effect the rate of brain tissue loss compare to healthy brain
Participants will give blood samples, complete MRI scans, and neuropsychological assessment measures.
Researchers will compare results between healthy control group and TBI group to determine changes in injured brains.
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
- 是
入选标准
- •Age 18-65, inclusive
- •History of non-penetrating TBI of at least moderate severity (defined by evidence of trauma-related neuroimaging abnormality on cranial computerized tomography (CT) scan.
- •High-velocity, high-impact injury mechanism consistent with diffuse axonal injury (e.g., motor vehicle accident, fall from height, etc.)
- •Immediate loss of consciousness (cases with delayed loss of consciousness due to expanding lesions will be excluded)
排除标准
- •History of premorbid disabling neurological or psychiatric disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, HIV-encephalitis)
- •History of premorbid disability condition that would interfere with outcome assessments
- •Bilaterally absent pupillary Reponses
- •Penetrating TBI
- •Elevated intracranial pressure (≥ 17 mmHg) 6 Contradictions to contrast-enhanced MRI (e.g., ferromagnetic implants, pregnancy, allergy to gadolinium contrast, renal impairment [GFR < 60ml/g/m3], claustrophobia, hemodynamic instability)
- •Prisoners, patients in police custody
- •Objective lung disease (PaCO2 at rest > 50 mmHg or venous serum bicarbonate > 26 mEg/L) based on any labs available for review from patient's clinical care. Note that these will not be checked solely for study purposes 9.Requiring portable oxygen at enrollment
- •Chronic heart failure, severe pulmonary disease
- •Current substance abuse that precludes participation and follow-up in the study, as determined by the study investigators
- •If there is medical or other disability that precludes completion of the study procedures as determined by the study investigators
结局指标
主要结局
Brain Atrophy
时间窗: 3 years
Rate of brain tissue volume loss quantified from serial brain MRI examinations
次要结局
未报告次要终点
研究者
研究点 (1)
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