Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Early neurological deterioration (END)
研究概览
简要总结
This multicenter observational study will explore the risk factors of early neurological deterioration(END) in patients with primary and to investigate the association between END and outcome.
详细描述
Neurological deterioration affects approximately one-third of patients with primary intracerebral hemorrhage (ICH) and increases the risk of death and dependency. However, the risk factors of early neurological deterioration (END), such as biochemical parameters, neuroimaging, and systemic complications, are not well documented in primary ICH, and the effective predictors of END is unknown.
This multicenter observational study aims to seek out the risk factors of END in patients with primary ICH and to investigate the association between END and outcome.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of primary intracerebral hemorrhage
排除标准
- •Patients with secondary
- •Undergo surgical evacuation of hematoma；
- •Presenting contraindications or refusal to MRI
- •Is pregnant
- •Patients refuse to be followed up for any reasons.
结局指标
主要结局
Early neurological deterioration (END)
时间窗: 48 hours after admission
END is defined as an increase in the total NIHSS score of ≥ 4 points within the first 48 h after admission
次要结局
- The quality of life(90 days, 1 year, 2 years after admission)
- Late neurological deterioration (LND)(7 days)
- Cognitive function(90 days, 1 year, 2 years after admission)
- Functional outcome(90 days, 1 year, 2 years after admission)
- Hematoma expansion(24 hours after admission)
- Depression status(90 days, 1 year, 2 years after admission)