National Stroke Research Institute, The Florey Institute for Neurosciences and Mental Health, Melbourne Brain Centre, Austin Campus, 245 Burgundy Street, Heidelberg, VIC 3084, Australia; University of Melbourne, Melbourne, VIC, Australia.
National Stroke Research Institute, The Florey Institute for Neurosciences and Mental Health, Melbourne Brain Centre, Austin Campus, 245 Burgundy Street, Heidelberg, VIC 3084, Australia.
J Clin Neurosci. 2014 Jul;21(7):1215-9. doi: 10.1016/j.jocn.2013.10.033. Epub 2014 Jan 29.
To increase the percentage of acute stroke patients benefiting from thrombolysis, the utility of expanding the time window of treatment beyond 4.5 hours after stroke onset needs to be investigated. We aimed to identify the target population and the challenges of recruitment of patients for the time window beyond 4.5 hours. Extending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND), a multicentre randomised controlled trial testing the efficacy of thrombolytic therapy in patients with clinically significant ischaemic penumbra between 4.5 to 9 hours after stroke onset, was used as a model to evaluate inclusion and exclusion criteria for late thrombolysis trials. Data from all stroke patients admitted to Austin Health over a 1 year period were retrospectively analysed. Case notes were examined to determine potential trial eligibility. Of 556 patients assessed, 95 (17%) presented during the EXTEND time window. Sixty-seven of these (70.5%) were wake-up strokes (WUS) and 28 (29.5%) arrived between 4.5 and 9 hours after symptoms onset. At least one exclusion criterion was found for 78 (82%) of them. Hence, 17 (3%) patients arrived within an appropriate time frame for the study without any exclusion criteria. Most of these (13) arrived outside routine MRI hours. The number of patients recruited would have increased more than three-fold if imaging had been available 24 hours, 7 days a week. A significant proportion (17%) of ischaemic stroke patients presented between 4.5 and 9 hours after stroke onset. The majority of these were WUS. The major challenge identified for patient recruitment was imaging availability.
为了提高急性中风患者接受溶栓治疗的比例,需要研究将治疗时间窗从中风发作后 4.5 小时扩展到 4.5 小时以上的效果。我们旨在确定目标人群,并发现招募超过 4.5 小时时间窗患者的挑战。EXTEND 试验(一项评估中风发作后 4.5 至 9 小时之间有临床意义的缺血半影区患者溶栓治疗疗效的多中心随机对照试验)作为模型,用于评估晚期溶栓试验的纳入和排除标准。回顾性分析了在 1 年期间入住 Austin Health 的所有中风患者的数据。检查病历以确定潜在的试验入选标准。在评估的 556 名患者中,95 名(17%)符合 EXTEND 时间窗标准。其中 67 名(70.5%)为觉醒性中风(WUS),28 名(29.5%)在症状发作后 4.5 至 9 小时之间到达。其中 78 名(82%)至少存在一个排除标准。因此,没有任何排除标准且符合研究条件的患者有 17 名(3%)。其中大多数(13 名)是在常规 MRI 时间之外到达的。如果每周 7 天、每天 24 小时都能进行影像学检查,那么可以招募的患者数量将增加三倍以上。在中风发作后 4.5 至 9 小时之间就诊的缺血性中风患者比例相当高(17%)。其中大多数是 WUS。患者招募的主要挑战是影像学检查的可用性。