Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 353
- 试验地点
- 2
- 主要终点
- Modified Rankin Scale score
研究概览
简要总结
In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH) increase with age. In patients older than 70 years, the occurrence of SAH exposes them to high risk of morbidity and a poor quality of life.
In this age bracket, the single randomized which compared endovascular coiling to microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased after coiling. Moreover, some prospectives studies about endovascular coiling described favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a procedural complication rate in 13% to 19%. From prospectives series, the proportion of favorable outcome after microsurgical clipping was estimated around 66% but the procedural complications are few reported. The outcome for patients treated conservatively was catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of patients.
The study hypothesis is that, in this age class, no difference exists between the 2 obliteration procedures.
An accurate evaluation of result in term of functional disability, quality of life and prognosis predictive factors seems a judicious question.
详细描述
The aim of our study was to determine a significant difference in terms of functional disability between microsurgical clipping and endovascular coiling in the elderly population.
Randomized multicenter trial: 2 randomized arms (clipping and coiling) plus 3 observational prospective arms (clipping, coiling, conservative).
Inclusion time: 48 months. Follow up: 12 months. Monitoring: 6 months. Duration of the trial: 66 months. Major end point: proportion of patients with unfavourable outcome at 12 months (mRS > 2).
Secondary end point: Quality of life at 12 months (EORTC scale), causes of morbidity (mRS > 2) and mortality, Dysautonomia according to the ADL and IADL scales.
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
- 70 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years old and more
- •Subarachnoid hemorrhage in grade I-IV of WFNS scale
- •Ruptured cerebral aneurysm diagnosed on multislice computed tomography angiography or cerebral angiography
- •treatment of subarachnoid hemorrhage
排除标准
- •Patients in grade V of WFNS scale
- •Subarachnoid hemorrhage without cerebral aneurysm
- •Patients with cerebral dementia, neurologic or psychiatric antecedents
结局指标
主要结局
Modified Rankin Scale score
时间窗: 12 months
次要结局
- Min Mental State Examination(12 months)
- Causes of morbidity and mortality(12 months)
- Hydrocephalus and risk factors(12 months)
- Quality of LIfe, QLQ C30 questionnaire from EORTC(12 months)
- Self-maintaining and instrumental activities of daily living, ADL and IADL score(12 months)