Department of Neurology Service, Center Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.
Neuroradiology. 2012 Jun;54(6):579-88. doi: 10.1007/s00234-011-0944-1. Epub 2011 Aug 2.
Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset.
Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria.
At baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm(3) in the treatment arm and 29 (8-105) cm(3) in the placebo arm.
This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established.
发病时间不明的脑卒中患者通常被排除在急性再通治疗之外。我们设计了一项初步研究，以评估基于灌注 CT（PCT）的溶栓治疗在存在缺血性梗死风险组织且发病时间不明的脑卒中患者中的可行性。
大脑中动脉区发病时间不明的幕上脑卒中患者，且 PCT 显示有大量的危险组织，将这些患者随机分为静脉溶栓组（阿替普酶 0.9mg/kg）和安慰剂组。可行性终点是患者在入院后 2 小时内随机分组和接受盲法治疗，以及正确应用（估计）灌注成像标准。
在基线时，溶栓组（n=6）的年龄（69.5[57-78]岁）比安慰剂组（n=6）的年龄（49[44-78]岁）有偏高的趋势。在可行性方面，有 3 例（25%）患者的医院到达至治疗的时间延迟超过 2 小时的限制。有 2 例（17%）违反 PCT 方案，均低估了安慰剂组随机分组患者的预计梗死体积。在第 7 天内没有发生症状性出血或死亡。溶栓组和安慰剂组各有 4 例（75%）和 5 例（20%）患者血管再通。治疗组未梗死的危险组织体积为 84（44-206）cm3，安慰剂组为 29（8-105）cm3。
这项初步研究表明，如果解决了治疗延迟和可靠识别缺血性梗死危险组织等问题，对发病时间不明的脑卒中患者进行基于 PCT 的随机溶栓试验可能是可行的。这种方法的安全性和效率需要进一步确定。
