Bowry Ritvij, Parker Stephanie, Rajan Suja S, Yamal Jose-Miguel, Wu Tzu-Ching, Richardson Laura, Noser Elizabeth, Persse David, Jackson Kamilah, Grotta James C
From the Department of Neurology (R.B., S.P., T.-C.W., E.N., K.J.), School of Public Heath (S.S.R., J.-M.Y.), and Department of Emergency Medicine (D.P.), University of Texas Health Science Center, Houston; Frazer Ltd, Houston, TX (L.R.); and Clinical Innovation and Research Institute, Memorial Hermann Hospital, Houston, TX (J.C.G.).
Stroke. 2015 Dec;46(12):3370-4. doi: 10.1161/STROKEAHA.115.011093. Epub 2015 Oct 27.
Faster treatment with intravenous tissue-type plasminogen activator (tPA) is likely to improve outcomes. Optimizing prehospital triage by mobile stroke units (MSUs) may speed treatment times. The Benefits of Stroke Treatment Delivered Using a Mobile Stroke Unit (BEST-MSU) study was launched in May 2014 using the first MSU in the United States to compare stroke management using an MSU versus standard management (SM). Herein, we describe the results of the prespecified, nonrandomized run-in phase designed to obtain preliminary data on study logistics.
The run-in phase consisted of 8 MSU weeks when all-patient care occurred on the MSU and 2 SM weeks when the MSU nurse met personnel on scene or at the emergency department to ensure comparability with MSU patients. Telemedicine was independently performed in 9 MSU cases.
Of 130 alerts, 24 MSU and 2 SM patients were enrolled. Twelve of 24 MSU patients received tPA on board; 4 were treated within 60 minutes of last seen normal, and 4 went on to endovascular treatment. There were no hemorrhagic complications. Four had primary intracerebral hemorrhage. Agreement on tPA eligibility between the onsite and telemedicine physician was 90%.
The run-in phase provided a tPA treatment rate of 1.5 patients per week, assured us that treatment within 60 minutes of onset is possible, and enabled enrollment of patients on SM weeks. We also recognized the opportunity to assess the effect of the MSU on endovascular treatment and intracerebral hemorrhage. Challenges include the need to control biased patient selection on MSU versus SM weeks and establish inter-rater agreement for tPA treatment using telemedicine.
静脉注射组织型纤溶酶原激活剂(tPA)进行更快治疗可能会改善预后。通过移动卒中单元(MSU)优化院前分诊可能会加快治疗时间。2014年5月启动了使用美国首个MSU的移动卒中单元卒中治疗效益(BEST-MSU)研究,以比较使用MSU与标准管理(SM)的卒中管理。在此,我们描述了预先指定的非随机导入期的结果,该导入期旨在获取有关研究后勤的初步数据。
导入期包括8个MSU周,在此期间所有患者护理均在MSU上进行,以及2个SM周,在此期间MSU护士在现场或急诊科与人员会面,以确保与MSU患者具有可比性。9例MSU病例独立进行了远程医疗。
在130次警报中,24例MSU患者和24例SM患者入组。24例MSU患者中有12例在转运途中接受了tPA治疗;4例在最后一次正常状态后60分钟内接受治疗,4例继续接受血管内治疗。无出血并发症。4例为原发性脑出血。现场医生与远程医疗医生对tPA治疗资格的一致性为90%。
导入期tPA治疗率为每周1.5例患者,向我们保证了发病后60分钟内进行治疗是可行的,并使SM周的患者能够入组。我们还认识到有机会评估MSU对血管内治疗和脑出血的影响。挑战包括需要控制MSU周与SM周患者选择的偏差,以及建立使用远程医疗进行tPA治疗的评分者间一致性。