Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 880
- 试验地点
- 6
- 主要终点
- The score on the modified Rankin Scale at 1 year after onset of symptoms.
研究概览
简要总结
The SPARTA study is a prospective multicenter observational trial in the Netherlands with the aim of identifying the best clinical care in patients with aneurysmal subarachnoidal haemorrhage. Differences in outcome between surgical treatment and endovascular treatment will be explored.
Furthermore, cost effectiveness and radiological prognostic factors will be examined.
详细描述
Rationale:
Ruptured intracranial aneurysms resulting in subarachnoid haemorrhage can be treated by open surgical treatment or endovascular treatment. Despite multiple previous studies, biases and uncertainty around the best current treatment practice still exist. The resulting variation of care may result in a variable outcome. The protocol for a prospective multicentre observational study aimed at comparing the effectiveness of different treatment strategies in patients with ruptured aneurysms is presented.
Objective:
The primary aim of this study is to identify the effectiveness of clipping versus coiling on functional outcome in patients presenting with a subarachnoid haemorrhage due to a ruptured intracranial aneurysm 1 year after onset of symptoms. Secondary objectives include long term functional outcome, complications, cost-effectiveness and explorative analysis of the diagnostic and prognostic value of radiological imaging.
Study design:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of subarachnoid haemorrhage on CT-scan or lumbar puncture (in the presence of a negative CT-scan)
- •Intracranial aneurysm proven within 6 months to be the cause of subarachnoid haemorrhage
- •Age 18 years or over at presentation.
- •Written informed consent
排除标准
- •Subarachnoid haemorrhage deemed most likely of 'perimesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)
- •Subarachnoid haemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging)
- •Diagnosis of intracerebral arteriovenous malformations or dural arteriovenous fistula.
- •No diagnosis of intracranial aneurysm at 6 months after onset of symptoms.
- •Not mastering the Dutch language
结局指标
主要结局
The score on the modified Rankin Scale at 1 year after onset of symptoms.
时间窗: 1 year after onset of symptoms
Scoring of functional outcome using the modified Rankin Scale. The scale has a minimum value of 0, meaning no symptoms, and a maximum value of 6, meaning dead. The modified Rankin Scale measures the degree of dependence. A higher score means a worse outcome.
次要结局
- modified Rankin Scale at 6 months, 1, 2, 5 and 10 years after onset of symptoms, as measured by completion of case report forms by local treating teams(6 months, 1, 2, 5 and 10 years after onset of symptoms)
- Modified Telephone Interview for Cognitive Status at 6 months, 1, 2, 5 and 10 years after onset as measured by completion of case report forms by local treating teams(6 months, 1, 2, 5 and 10 years after onset of symptoms)
- 5-level EuroQol-5D questionnaire at 6 months, 1, 2, 5 and 10 years after onset of symptoms, as measured by completion of questionnaires by subjects(6 months, 1, 2, 5 and 10 years after onset of symptoms)
- Health associated costs questionnaire(3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms)
研究者
Wouter Moojen
Principal Investigator
Haaglanden Medical Centre