Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Glasgow Outcome Scale Extended
研究概览
简要总结
Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome.
详细描述
In order to identify patients with a good neurological outcome a combination of diagnostic tests is used.
Clinical rating scales
- Simplified evaluation of consciousness scale (SECONDs) and the full outline of unresponsiveness (FOUR) score
- Once a week
Blood biomarkers
- Neuron specific enolase, neurofilament light, glial fibrillary acidic protein
- Sampling timepoints: 24h, 72h, 7 days and 14 days after brain injury
- Serum (STG-5) and plasma (EDTA-6) tubes, aliquoted (4 x 0.5ml) and stored at -80°C
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients that are admitted to the ICU with the following criteria will be eligible for inclusion:
- •Severe brain injury (GCS ≤ 8) as a result of:
- •Traumatic brain injury
- •Ischemic cerebrovascular accident
- •Intracranial hemorrhage
- •Meningo-encephalitis
- •Subarachnoid hemorrhage
- •Age ≥ 18 years old
- •Written informed consent from legal representatives
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Absence of informed consent
- •Moribund at ICU admission
- •Progressive neurodegenerative disease
- •Pre-admission life expectancy ≤ 6 months based on comorbidity
- •GCS has been > 8 prior to inclusion
- •Impossible to include within 24 hours after brain injury
结局指标
主要结局
Glasgow Outcome Scale Extended
时间窗: 6 months
次要结局
- Glasgow Outcome Scale Extended(12 months)
研究者
prof. dr. Janneke Horn
prof. dr. J. Horn
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)