Department of Neurology, Xijing Hospital, No, 15 West Changle Road, Xi'an, China, 710032.
BMC Neurol. 2012 Oct 30;12:127. doi: 10.1186/1471-2377-12-127.
Both severe stenosis and completed occlusion in internal carotid artery or its distal branches have been considered the main reasons of cerebral hypoperfusion, which contributes to the washout disturbances of embolism in low perfusion territories distal to stenosis. An aggravated hypoperfusion state in certain brain region may induce ischemic stroke and further cognitive decline. However, the effective medication for cerebral hypoperfusion is largely unsettled.
METHODS/DESIGN: By using computed tomography perfusion (CTP) imaging, the trial will evaluate the effectiveness, safety and tolerability of hydroxyethyl starch (HES) 130/0.4 for patients with extra-/intra-cranial artery stenosis and cerebral hypoperfusion. From 5 neurological inpatient wards, 300 patients will be randomly recruited for administered routine medications plus intravascular volume therapies using the equal volume of HES 130/0.4 or 0.9% sodium chloride solution. Cerebral hypoperfusion state after 7-day intervention is the primary outcome measure. The secondary outcome measures includes, impaired renal function, abnormal heart function, hematological changes, neurological dysfunctions and cerebrovascular events in peri-intervention period and/or 3-month follow-up. The sample size will allow the detection of a two-sided 5% significance level between groups in the endpoint with a power of 80%.
The trial would provide important efficacy and safety data on the intravascular administration of HES 130/0.4 in patients with unilateral cerebral hypoperfusion. The effects on kidney function, heart function, coagulation, neurological function and cerebralvascular events will be assessed.
ClinicalTrials.gov (Identifier: NCT01192581).
颈内动脉或其远端分支的严重狭窄和完全闭塞已被认为是脑灌注不足的主要原因，这导致狭窄下游低灌注区的栓子洗脱紊乱。特定脑区的灌注恶化状态可能导致缺血性卒中，并进一步导致认知能力下降。然而，针对脑灌注不足的有效药物仍未确定。
方法/设计：本试验将通过计算机断层灌注（CTP）成像评估羟乙基淀粉 130/0.4 对颅内外动脉狭窄合并脑灌注不足患者的有效性、安全性和耐受性。试验将从 5 个神经内住院病房中随机招募 300 例患者，分别接受常规药物治疗加等体积羟乙基淀粉 130/0.4 或 0.9%氯化钠溶液的血管内容量治疗。干预后 7 天的脑灌注不足状态是主要观察终点。次要观察终点包括干预期和/或 3 个月随访期间的肾功能受损、心功能异常、血液学变化、神经功能障碍和脑血管事件。该样本量将允许在终点检测组间双侧 5%显著性水平，具有 80%的效能。
该试验将为羟乙基淀粉 130/0.4 血管内给药治疗单侧脑灌注不足患者提供重要的疗效和安全性数据。还将评估其对肾功能、心功能、凝血、神经功能和脑血管事件的影响。
ClinicalTrials.gov（标识符：NCT01192581）。
