NCT04945603招募中不适用
Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 10
- 主要终点
- Clinical Outcome
研究概览
简要总结
Multicentric registry study in order to define outcome, predictors, treatment effects and their modifiers in poor grade aneurysmal subarachnoid haemorrhage patients.
The search for outcome predictors is going to be subdivided into three main research areas:
- outcome predictors in the emergency department (so called "early brain injury phase").
- outcome predictors in the neurocritical care unit (so called "delayed brain injury phase").
- Treatment strategies. Two other areas of research are identified: delayed cerebral ischemia (incidence, treatment, predictors, impact on outcome) and long term follow-up (recent evidences suggest that there may be a non-negligible proportion of poor grade subarachnoid hemorrhage patients who may benefit from substantial improvement at long-term (after 6-12 months of follow-up).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification.
排除标准
- •Patients younger than 18 years old.
- •Pregnant or breast-feeding patients.
- •Aneurysmal subarachnoid hemorrhage due to trauma or vascular malformations other than cerebral aneurysms.
结局指标
主要结局
Clinical Outcome
时间窗: 12 months
modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability.
次要结局
- Rebleeding(onset-48hours)
- Delayed Cerebral Ischemia(onset-30 days)
- Long-Term clinical outcome(12-60 months)
- Decompressive Craniotomy(onset-3 weeks)
- Treatment Complications(onset-1 week)
- CSF drainage(onset-3 weeks)
- Volumetric analysis of intracranial bleeding(onset-24hours)
- Volumetric analysis of delayed cerebral ischemia(onset-3 weeks)
- Ventriculo-peritoneal shunt(onset-4 weeks)
研究者
Pietro Panni
Principal Investigator
IRCCS San Raffaele
研究点 (10)
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