MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Delayed Cerebral Ischemia
研究概览
简要总结
The purpose of this study is to validate results from a related trial (NCT01791257) and to compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with and without systemic complications.
详细描述
In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to validate former results from CSF studies through microRNA profiling investigate the pathophysiological mechanisms that lead to systemic complications such as cardiac dysfunction, acute lung injury (ALI) and systemic inflammatory response syndrome(SIRS).
We will accomplish this through analyzing the profile of microRNA expression in blood and cerebrospinal fluid from SAH patients.
Validation:
As in our earlier study we wish to compare the expression of 20 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. In addition, some of the patients will have established invasive neuromonitoring including microdialysis in which we will study changes of certain microRNAs.
DCI as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395:
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Delayed Cerebral Ischemia
时间窗: 21 days
Delayed Cerebral Ischemia as defined by Vergouwen et al\[1\]. In our earlier study we found the clinical condition DCI somehow subjective which is why we added the following two primary outcome measures. Comparing microRNA profiles between groups with or without.
Delayed Cerebral infarction
时间窗: 21 days
as defined by Vergouwen et al \[1\]. Comparing microRNA profiles between groups with or without.
Delayed Cerebral Ischemia and Cerebral infarction
时间窗: 21 days
as defined by Vergouwen et al \[1\]. Comparing microRNA profiles between groups with or without.
次要结局
- Acute Lung Injury(21 days)
- Systemic Inflammatory Response Syndrome(21 days)
- Early Brain Injury(Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated))
- Cardiac Dysfunction(21 days)
研究者
Søren Bache, MD
MD
Rigshospitalet, Denmark