Berlin - Specific Acute Treatment in Ischemic or Haemorrhagic Stroke With Long Term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,246
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific Treatments such as endovascular treatment. It will also enable the participating hospitals to compare the quality of care of their facility. At the same time, B-SPATIAL will provide an opportunity of scientific evaluation of new therapeutic procedures or specific treatments in stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will allow for an identification of key quality indicators that assure valid quality assessment aiming at a reduced documentation load for future quality management.
详细描述
- Background
Quality assessment of acute stroke care is organized in regional stroke registries in Germany - for the federal state of Berlin in the Berlin Stroke Registry (BSR). The current documentation of the Berlin Stroke Registry is focused on the documentation of process quality in participating hospitals.
So far, outcome quality is only assessed by surrogate parameters such as complications and mortality during in-hospital stay. However, according to consensus recommendations, disability-free survival versus death and dependency is the most important outcome measure after acute stroke. Because of the high variability of the clinical course after stroke, this outcome is generally assessed after three months by using the modified Rankin Scale (mRS). 2. Motivation
In early 2015, several published trials showed that mechanical thrombectomy improves the prognosis of ischemic stroke patients with acute large artery occlusion of proximal brain supplying arteries. Currently, this invasive catheter based treatment is not available in many hospitals with acute Stroke Unit. It is likely that the quality of technical procedures depends on the expertise and experience of treating interventionalists. Current studies suggest a close relationship between effectiveness of the approach and time to treatment, similar to intravenous thrombolysis. This time dependency makes prehospital triage more challenging because selection of the appropriate facility is likely to influence patient outcome.
Intracerebral hemorrhage (ICH) is less frequent than ischemic stroke but is associated with worse prognosis. Recent studies suggest that blood pressure lowering may improve prognosis if started during the hyperacute phase of ICH. With limited scientific evidence, many patients undergo neurosurgical intervention. It remains unclear whether delivery of hemorrhagic stroke patients to hospitals with neurosurgery leads to better 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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Modified Rankin Scale
时间窗: 3 months
Assessment of functional outcome over the entire range of the modified Rankin Scale
次要结局
未报告次要终点
研究者
Heinrich J Audebert
Prof. Dr. med.
Charite University, Berlin, Germany
