MicroRNA Expression in Cerebrospinal Fluid From Patients Suffering Subarachnoid Hemorrhage With and Without Delayed Cerebral Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Delayed Cerebral Ischemia - Clean groups
研究概览
简要总结
The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.
详细描述
In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to investigate the pathophysiological mechanisms that lead to the phenomenon delayed cerebral ischemia (DCI).
We will accomplish this through analyzing the profile of microRNA expression in the cerebrospinal fluid of SAH patients treated with extraventricular drainage.
At first we wish to compare the expression of 376 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in cerebrospinal fluid drawn on day 5 after ictus.
Secondly specific microRNAs of interest in which the expression differs between group 1 and 2 are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.
Should we find no differently expressed specific microRNAs we will compare the expression of microRNA in group 1+2 with group 3.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patient admitted to the neurointensive care unit with aneurismal subarachnoid hemorrhage
- •External ventricular drainage with 5 days of ictus
- •Age > 18 years
排除标准
- •Glasgow Coma Score (GCS) continuously < 7 during the first 5 days following ictus
- •A known and proven complication (rebleeding, clip/coil complication, cardiopulmonal complication requiring full sedation, ventriculitis e.g.) leads to a GCS < 7 thereby preventing the detection of DCI.
结局指标
主要结局
Delayed Cerebral Ischemia - Clean groups
时间窗: 21 days
Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. We found confirmation/exclusion of DCI difficult in a few patients. To minimize error, two clinicians reviewed all clinical, biochemical and radiological data, obtained 3 weeks from ictus, and independently assessed if any clinical deterioration fulfilled the criteria of delayed cerebral ischemia. Furthermore, included patients were categorized as "definitely DCI", "probably DCI", "probably not DCI" or "definitely not DCI". Therefore we decided to modify our primary outcome measure in this case-control study to compare "definitely DCI" vs. "definitely not DCI".
次要结局
- Relation of microRNA profile to cerebral infarction as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.(Following a blinded description of CT-scans)
- Early brain injury: Comparison of microRNA profiles with clinical neurology following occlusion of the aneurysm(Assessed at the first wake-up call following clip or coil)
- Association of microRNA-profile with 3 month outcome(Follow up examination at 3 month or as close to this)
- Relation of microRNA profile to the regional area of cerebral injury(Following a blinded description of CT-scans)
- Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. Large groups.(21 days following ictus)
研究者
Søren Bache Larsen, MD
MD
Rigshospitalet, Denmark