Registry of Acute Stroke Under New Oral Anticoagulants -Pilot (RASUNOA-Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- Rate of hematoma expansion (ICH)
研究概览
简要总结
The registry of acute stroke under new oral anticoagulants (RASUNOA) is a German multicenter, prospective, observational registry performed at about 50 study centers covering about 50.000 acute ischemic strokes and 6000 acute intracranial hemorrhages per year. Study enrollment will be consecutive. The RASUNOA registry study center is the University Medical Center of the Principal Investigator (Heidelberg, Germany). The registry will focus on treatment decisions and concepts in patients being under treatment with a new oral anticoagulant and suffering from acute ischemic or hemorrhagic stroke.
详细描述
The main purpose of the study is to collect information from a large, prospectively enrolling multicentre stroke database regarding the optimal management of ischemic and hemorrhagic stroke during anticoagulation with nOAC. Specifically, we aim to obtain critical information regarding the epidemiology, natural history, laboratory and neuroradiological aspects, clinical consequences, and the effects of treatment (i.e. thrombolysis/interventional recanalisation in ischemic stroke and hemostatic therapy in ICH, respectively) in stroke during nOAC. The Registry is not limited to a specific new OAC but intends to examine stroke during use of any of the approved nOAC. The study is not designed to perform comparisons among the different nOAC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •age >= 18 years
- •informed consent
- •acute stroke or intracranial bleeding
- •therapy with a new oral anticoagulant (Dabigatran®, Rivaroxaban®, Apixaban®, Edoxaban®)
排除标准
- •missing informed consent
结局指标
主要结局
Rate of hematoma expansion (ICH)
时间窗: 48h after ICH
Rate of hematoma enlargement in patients with ICH between initial imaging and follow-up imaging (CT)
Symptomatic intracerebral haemorrhage after thrombolysis
时间窗: 24 h
In patients with ischemic stroke while under treatment with any of the new OAC who receive thrombolysis we will measure any hemorrhagic transformation on routine follow-up CT imaging (usually within 24h after thrombolysis)
次要结局
未报告次要终点
研究者
Prof. Roland Veltkamp
Senior Physician, Department of Neurology, University Hospital Heidelberg
University Hospital Heidelberg