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临床试验/NCT03027453
NCT03027453已完成不适用

Berlin - Specific Acute Treatment in Ischemic or Haemorrhagic Stroke With Long Term Follow-up

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 15,246 人开始时间: 2016年1月最近更新:
适应症

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

  1. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heinrich J Audebert

Prof. Dr. med.

Charite University, Berlin, Germany

研究点 (1)

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