title: Hydroxyethyl starch 130/0.4 and sodium chloride injection as adjunctive therapy in patients with cerebral hypoperfusion.
abstract: 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
  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%.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov (Identifier: NCT01192581).
authors.affiliation: Department of Neurology, Xijing Hospital, No, 15 West Changle Road, Xi'an, China, 710032.
authors.forename: Junliang
authors.initials: J
authors.lastname: Han
authors.forename: Fang
authors.initials: F
authors.lastname: Yang
authors.forename: Wenrui
authors.initials: W
authors.lastname: Jiang
authors.forename: Guangyun
authors.initials: G
authors.lastname: Zhang
authors.forename: Zhirong
authors.initials: Z
authors.lastname: Liu
authors.forename: Xuedong
authors.initials: X
authors.lastname: Liu
authors.forename: Feng
authors.initials: F
authors.lastname: Xia
authors.forename: Ya
authors.initials: Y
authors.lastname: Bai
authors.forename: Junhong
authors.initials: J
authors.lastname: He
authors.forename: Manxiang
authors.initials: M
authors.lastname: Chao
authors.forename: Gang
authors.initials: G
authors.lastname: Zhao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001921:Brain / Q000000981:diagnostic imaging; D002343:Carotid Artery, Internal / Q000000981:diagnostic imaging; D016893:Carotid Stenosis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D002561:Cerebrovascular Disorders / Q000000981:diagnostic imaging / Q000188:drug therapy*; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011859:Radiography; D012107:Research Design; D012965:Sodium Chloride / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D020521:Stroke / Q000000981:diagnostic imaging / Q000188:drug therapy*
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D012965:Sodium Chloride