Pilot Study on the Role of Neuroinflammation in the Pathophysiology of Subarachnoid Hemorrhage and the Value of the Bilateral Bispectral Index for Early Diagnosis of Cerebral Ischemia After Subarachnoid Hemorrhage.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bilateral Bispectral Index
研究概览
简要总结
Subarachnoid hemorrhage (SAH) is associated with a high mortality and frequently leads to severe disability in survivors caused by cerebral vasospasm and infarction.
This study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of the bilateral bispectral index (BIS) for the early diagnosis of cerebral vasospasm.
详细描述
Subarachnoid hemorrhage (SAH) or bleeding in the brain is a form of stroke. SAH mostly results from ruptured aneurysms. This severe disease often results in death or severe physical or cognitive disabilities and reduced quality of life. One frequent complication after SAH is cerebral vasospasm, a spasm of the big arteries accompanied by infarction of healthy brain tissue. The pathophysiologic processes which drive vasospasm remain unclear. This study aims to examine the role of endocannabinoids and cortisol in cerebrospinal fluid during the development of cerebral vasospasm. Additionally, this study examines whether side difference in the processed electroencephalogram (bilateral bispectral index) may be useful for early detection of cerebral vasospasm.
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
- •Admission to neurosurgical ICU Klinikum der Universität München
- •External CSF drainage
排除标准
- •AGE < 18
结局指标
主要结局
Bilateral Bispectral Index
时间窗: Every second from 0:01 am until 23:59 pm on hospital day 1,2,3,4,5,6,7,8,9,10,11,12,13,14
The Bispectral Index is calculated every second by the BIS Vista monitor. These data will be recorded continuously from 0:01 am until 23:59 pm.
Concentrations of endocannabinoids and corticoids in cerebrospinal fluid and blood.
时间窗: Once per day from day 1 until day 14 after hospital admission
Samples of cerebrospinal fluid and blood will be collected every day at 8am on hospital day 1-14 and the concentrations of the following substances will be determined: 1. Anandamide 2. 2-arachidonoylglycerol 3. 2-arachidonoylglycerol-ether 4. N-arachidonoyldopamine 5. N-arachidonylglycine 6. O-arachidonylethanolamide 7. Palmitoylethanolamide 8. Cortisol 9. Corticotropin-releasing hormone (in CSF only) 10. Corticosteroid-binding globulin (in blood only)
次要结局
- Transcranial Doppler(Every day at 8 am from day 1 until day 14 after hospital admission)
研究者
Cyrill Hornuss
Study Principal Investigator
Ludwig-Maximilians - University of Munich