Scandinavian Multicentre Acute Subdural Hematoma (SMASH) Study: A Multi-national Population-based Consecutive Cohort
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,600
- 主要终点
- 30-day mortality (yes vs. no) in younger versus elderly
研究概览
简要总结
In a multi-national population-based cohort, the investigators want to compare the clinical course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (< 70 y/o) with acute subdural hematoma treated surgically. An improved understanding of the clinical outcome and the prognostic factors of acute subdural hematomas would allow physicians to make better decisions about treatment options in traumatic ASDH in the elderly population.
详细描述
Primary endpoint:
In a population based study to evaluate 30-day mortality (perioperative death) in younger versus elderly (≥70 years) patients with ASDH.
Secondary endpoint(s):
- Describe pattern of care in younger versus the elderly
- Clinical outcome (Glasgow outcome scale at 6-months (range, 3-12) follow-up in younger versus elderly (≥70 years) patients with ASDH:
- Good outcome predefined as GOS 4-5
- Unfavourable outcome predefined as GOS 1-3
- 30-day morbidity (according to the Ibanez classification) in younger versus elderly (≥70 years) patients with ASDH.
- To assess the effect of age as an independent prognostic factor in traumatic ASDH for outcome (GOS) in the elderly (≥70 years) using a three-step approach
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgically treated ASDH patients
排除标准
- •Post-operative ASDH (i.e. inclusion criteria post-traumatic)
- •Intracranial surgery within 6 months prior to trauma
- •Permanent intracranial device (i.e DBS electode, VP shunt etc.)
结局指标
主要结局
30-day mortality (yes vs. no) in younger versus elderly
时间窗: 30-day mortality after surgery
30-day mortality (yes vs. no) in younger versus elderly
次要结局
未报告次要终点
研究者
Jiri Bartek
MD
Karolinska University Hospital