Yuan Ziwen, Wang Bo, Li Feijiang, Wang Jing, Zhi Jin, Luo Erping, Liu Zhirong, Zhao Gang
Department of Neurology, Xijing Hospital, The Fourth Military Medical University, Xìan, China.
Department of Epidemiology, The Fourth Military Medical University, Xìan, China.
BMJ Open. 2015 May 15;5(5):e006704. doi: 10.1136/bmjopen-2014-006704.
The rate of intravenous thrombolysis with tissue-type plasminogen activator or urokinase for stroke patients is extremely low in China. It has been demonstrated that a telestroke service may help to increase the rate of intravenous thrombolysis and improve stroke care quality in local hospitals. The aim of this study, also called the Acute Stroke Advancing Program, is to evaluate the effectiveness and safety of decision-making concerning intravenous thrombolysis via a telemedicine consultation system for acute ischaemic stroke patients in China.
This is a multicentre historically controlled study with a planned enrolment of 300 participants in each of two groups. The telestroke network consists of one hub hospital and 14 spoke hospitals in underserved regions of China. The usual stroke care quality in the spoke hospitals without guidance from the hub hospital will be used as the historical control. The telemedicine consultation system is an interactive, two-way, wireless, audiovisual system accessed on portable devices. The primary outcome is the percentage of patients treated with intravenous thrombolysis within 4.5 h of stroke onset.
The project has been approved by the Institutional Review Board of Xijing Hospital. The results will be published in scientific journals and presented to local government and relevant institutes.
NCT02088346 (12 March 2014).
在中国,使用组织型纤溶酶原激活剂或尿激酶对中风患者进行静脉溶栓的比例极低。已有研究表明,远程卒中服务可能有助于提高静脉溶栓比例,并改善当地医院的卒中治疗质量。本研究(也称为急性卒中推进项目)的目的是评估通过远程医疗咨询系统对中国急性缺血性卒中患者进行静脉溶栓决策的有效性和安全性。
这是一项多中心历史对照研究,计划每组招募300名参与者。远程卒中网络由中国医疗服务不足地区的1家中心医院和14家基层医院组成。基层医院在没有中心医院指导情况下的常规卒中治疗质量将作为历史对照。远程医疗咨询系统是一种可在便携式设备上访问的交互式、双向、无线视听系统。主要结局是卒中发作后4.5小时内接受静脉溶栓治疗的患者百分比。
该项目已获得西京医院机构审查委员会的批准。研究结果将发表在科学期刊上,并提交给当地政府和相关机构。
NCT02088346(2014年3月12日)。