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Berlin PRehospital Or Usual Delivery of acute stroke care (B-PROUD)

柏林院前或常规急性中风护理 (B-PROUD)

基本信息

批准号：
283917568
负责人：
Professor Dr. Heinrich Audebert, since 4/2017
金额：
--
依托单位：
Centrum für Schlaganfallforschung Berlin (CSB)
依托单位国家：
德国
项目类别：
Clinical Trials
财政年份：
2016
资助国家：
德国
起止时间：
2015-12-31 至 2020-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/283917568?language=en
关键词：
Berlin PRehospital Usual Delivery acute

项目摘要

Pre-hospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. However, proof of improved functional outcome compared to usual care is still lacking. This pragmatic, prospective, blindedendpoint trial comparing functional outcomes of treatment candidates 3 months after stroke closes this gap. We will include patients whose emergency call from a predefined catchment area in Berlin, Germany, caused a stroke alarm at the dispatch center during stroke emergency mobile (STEMO) hours (7am-11pm, Monday-Sunday). STEMO is equipped with a computed tomography (CT) scanner including CT-angiography capability, point-of-care laboratory and telemedicine. A vascular neurologist, a paramedic and a radiology technician are abord. We define the primary study population as treatment candidates with a final discharge diagnosis of cerebral ischemia, onset-to-alarm time ¿ 4 hours, symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. With one STEMO per catchment area, about 40% of STEMO dispatches will be handled by regular ambulances since STEMO is already in operation for other patients. This will create a quasi-randomized control group. The results of this trial will inform decision makers on the effects of STEMO on functional outcome.

专门救护车提供的院前卒中护理可提高溶栓率、减少报警到治疗时间并改善院前分诊。然而，与常规护理相比，仍缺乏功能结果改善的证据。这项务实、前瞻性、盲态终点试验比较了中风后 3 个月治疗候选者的功能结果，缩小了这一差距。我们将纳入在中风急救移动 (STEMO) 时间内（周一至周日，上午 7 点至晚上 11 点）在调度中心发出中风警报的患者，这些患者来自德国柏林的预定服务区。 STEMO 配备计算机断层扫描 (CT) 扫描仪，包括 CT 血管造影功能、护理点实验室和远程医疗。一名血管神经科医生、一名护理人员和一名放射技术员均已离境。我们将主要研究人群定义为最终出院诊断为脑缺血、发病至报警时间为 4 小时、救护车到达时症状未解决、并且在紧急情况前能够在没有帮助的情况下行走的治疗候选者。由于每个服务区配备一台 STEMO，大约 40% 的 STEMO 调度将由常规救护车处理，因为 STEMO 已经在为其他患者提供服务。这将创建一个准随机对照组。该试验的结果将让决策者了解 STEMO 对功能结果的影响。