Multicenter Registry of Patients With Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
The purpose of this registry is to collect detailed information on the characteristics, treatment, and outcomes of patients with a subarachnoid hemorrhage. This information will enable research aimed at improving the safety and effectiveness of current and future treatments. By studying these data, the investigators aim to identify which treatment strategies offer the best results and which factors are most important in the care of patients with a subarachnoid hemorrhage. The knowledge gained from this research will help improve patient care in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Spontaneous subarachnoid hemorrhage with blood in the basal cisterns and/or major fissures on non-contrast head computed tomography (CT), or xanthochromia of cerebrospinal fluid confirmed by spectrophotometric analysis.
- •Eligible etiologies/patterns:
- •Aneurysmal SAH
- •SAH from other intracranial vascular malformation (e.g. AVM, dural AVF)
- •Perimesencephalic SAH
- •Non-perimesencephalic angiogram negative SAH
- •SAH from intracranial artery dissection
排除标准
- •Traumatic, neoplastic, infection related (except mycotic aneurysms), or iatrogenic SAH
- •Isolated convexity SAH
研究组 & 干预措施
Spontaneous Subarachnoid Hemorrhage
干预措施: None, observational study (Other)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 6 months ± 30 days after SAH
The Modified Rankin Scale (mRS) is a scale ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death. Higher scores indicate a worse outcome.
次要结局
- modified Rankin Scale (mRS)(18 months ± 30 days after SAH)
- Complications related to treatment of the ruptured aneurysm(Periprocedural)
- Complications related to SAH(During registry period (up to 18 months after SAH))
- Degree of aneurysm occlusion(Up to 18 months after SAH)
- Newly found aneurysm or other vascular malformation at additional imaging in patients with non-perimesencephalic primary angiogram negative SAH(Up to 18 months after SAH)
- Patient reported outcomes (PROMS): SOS-SAH(Up to 18 months ± 30 days after SAH)
- Patient reported outcomes (PROMS): Stroke Specific Quality of Life scale (SSQoL)(Up to 18 months ± 30 days after SAH)
- Patient reported outcomes (PROMS): EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Up to 18 months ± 30 days after SAH)
- Patient reported outcomes (PROMS): Hospital Anxiety and Depression Scale (HADS)(Up to 18 months ± 30 days after SAH)
- Patient reported outcomes (PROMS): The Cognition scale of the CheckList for Cognitive and Emotional consequences following stroke (CLCE-C)(Up to 18 months ± 30 days after SAH)
- Patient reported outcomes (PROMS): iMTA Medical Consumption Questionnaire (iMCQ)(Up to 18 months ± 30 days after SAH)
- Patient reported outcomes (PROMS): iMTA Productivity Cost Questionnaire (iPCQ)(Up to 18 months ± 30 days after SAH)
- Amsterdam Cognition Scan (ACS)(Up to 18 months ± 30 days after SAH)
研究者
Mervyn Vergouwen
Principal investigator
UMC Utrecht