Hydroxyethyl starch 130/0.4 and sodium chloride injection as adjunctive therapy in patients with cerebral hypoperfusion

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• 作者：Junliang Han (1)
  Fang Yang (1)
  Wenrui Jiang (2)
  Guangyun Zhang (1)
  Zhirong Liu (1)
  Xuedong Liu (1)
  Feng Xia (1)
  Ya Bai (1)
  Junhong He (1)
  Manxiang Chao (1)
  Gang Zhao (1)
  
• 刊名：BMC Neurology
• 出版年：2012
• 出版时间：December 2012
• 年：2012
• 卷：12
• 期：1
• 全文大小：253KB
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  31. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2377/12/127/prepub
  
• 作者单位：Junliang Han (1)
  Fang Yang (1)
  Wenrui Jiang (2)
  Guangyun Zhang (1)
  Zhirong Liu (1)
  Xuedong Liu (1)
  Feng Xia (1)
  Ya Bai (1)
  Junhong He (1)
  Manxiang Chao (1)
  Gang Zhao (1)
  
  1. Department of Neurology, Xijing Hospital, No. 15 West Changle Road, Xi鈥檃n, 710032, China
  2. Department of Cardiology, Tangdu Hospital, No. 1 Xinsi Road, Xi鈥檃n, China, 710038
  

文摘

Background 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%. Discussion 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. Trial registration ClinicalTrials.gov (Identifier: NCT01192581)