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Open Access Study protocol

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

Junliang Han1, Fang Yang1, Wenrui Jiang2, Guangyun Zhang1, Zhirong Liu1, Xuedong Liu1, Feng Xia1, Ya Bai1, Junhong He1, Manxiang Chao1 and Gang Zhao1*

Author affiliations

1 Department of Neurology, Xijing Hospital, No. 15 West Changle Road, Xi’an, China, 710032

2 Department of Cardiology, Tangdu Hospital, No. 1 Xinsi Road, Xi’an, China, 710038

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Citation and License

BMC Neurology 2012, 12:127  doi:10.1186/1471-2377-12-127

Published: 30 October 2012

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/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)