Extending Window of IV TPA for Brainstein and Cerebeller Stroke

临床和病理研究表明，后脑，特别是脑干， 比前脑结构对缺血的耐受性。在基底动脉血栓形成的患者中， 假设为目前的血运重建实践提供了理论基础， 症状发作。如果对这些患者有益处，无论机制如何（相对缺血耐受性， 侧支循环），基底动脉分支血栓患者很可能 也受益。目前，tPA延迟再灌注的益处在两个人群中均未得到证实。 该组代表了大量的患者：所有缺血性卒中中的10 - 20%位于脑梗死区域。 脑干或小脑。该研究是一项初步、单中心、随机、前瞻性、盲态安全性和 在脑干发作后3至24小时之间，在1小时内给予0.9 mg/kg iv t-PA的可行性试验 和/或小脑缺血性中风。在计算机断层扫描（CT）排除出血后， 将进行磁共振（MR）检查以确认脑干和/或小脑卒中。六十 将患者平均随机分配至治疗组或对照组。主要安全性终点为 输注后36小时内出现症状性颅内出血。如果神经系统疾病，将进行CT扫描。 下降发生。本研究的次要目的是获得疗效的初步数据（目的2）。 将记录输注后24小时、7-10天和90天的功能结局。率 24小时时NIH卒中量表改善> 8分，90天时功能结局， 治疗组之间的比较。将在24小时内重复进行MR扫描（血管再通， DWI病灶生长）和tPA输注后90天（最终梗死体积）。的增长率 24小时MR的DWI病变体积，24小时MRA的血管再通，最终病变体积和 将比较两组间90天MR时的病变生长。其他次要目的是调查 结果的临床和影像学预测因素（目标3），并评估牛津郡标准的准确性 (Aim 4）用于脑干和小脑卒中患者的鉴别。这些数据将用于 设计并计划在该患者人群中进行进一步研究。

Clinical and pathological studies indicate that the hindbrain, particularly the brainstem, has a greater tolerance to ischemia than the forebrain structures. In patients with basilar artery thrombosis, it is this hypothesis that provides the rationale for the current practice of revascularization up to 24 hours after symptom onset. If there is a benefit for these patients, whatever the mechanism (relative ischemic tolerance, collateral circulation), it is very likely that patients with thrombus in the branches of the basilar artery would benefit as well. Currently, the benefit of such delayed reperfusion with tPA is unproven in either population. This group represents a large number of patients: 10 to 20% of all ischemic strokes are located in the brainstem or cerebellum. The study is a pilot, single-center, randomized, prospective, blinded safety and feasibility trial of 0.9 mg/kg iv t-PA given over one hour between 3 to 24 hours after onset of brainstem and/or cerebellar ischemic stroke. After a computed tomographic (CT) scan to exclude hemorrhage, a magnetic resonance (MR) study will be obtained to confirm brainstem and/or cerebellar stroke. Sixty patients will be randomized evenly to treatment or control arms. The primary safety endpoint will be symptomatic intracranial hemorrhage within 36 hours after infusion. CT scans will be obtained if neurological decline occurs. Secondary aims of the present study are to obtain preliminary data on efficacy (Aim 2). Twenty-four hour post infusion, 7-10 day, and 90-day functional outcome will be recorded. The rate of improvement by > 8 points on the NIH Stroke Scale at 24 hours and functional outcome at 90 days will be compared between treatment groups. Repeat MR scans will be obtained 24 hours (vessel recanalization, DWI lesion growth) and 90 days (final infarct volume) after tPA infusion in all patients. The rate growth of the DWI lesion volume on 24 hour MR, vessel recanalization by MRA at 24 hours, the final lesion volume and lesion growth at 90 day MR will be compared between groups. Other secondary aims are to investigate clinical and imaging predictors of outcome (Aim 3), and to assess the accuracy of the Oxfordshire criteria (Aim 4) for the identification of patients with brainstem and cerebellar stroke. These data will be used to design and plan further investigation in this patient population.