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

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          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)

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          Most cited references30

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          Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association.

          The aim of this updated statement is to provide comprehensive and timely evidence-based recommendations on the prevention of ischemic stroke among survivors of ischemic stroke or transient ischemic attack. Evidence-based recommendations are included for the control of risk factors, interventional approaches for atherosclerotic disease, antithrombotic treatments for cardioembolism, and the use of antiplatelet agents for noncardioembolic stroke. Further recommendations are provided for the prevention of recurrent stroke in a variety of other specific circumstances, including arterial dissections; patent foramen ovale; hyperhomocysteinemia; hypercoagulable states; sickle cell disease; cerebral venous sinus thrombosis; stroke among women, particularly with regard to pregnancy and the use of postmenopausal hormones; the use of anticoagulation after cerebral hemorrhage; and special approaches to the implementation of guidelines and their use in high-risk populations.
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            MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis

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              Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial.

              Percutaneous transluminal angioplasty and stenting (endovascular treatment) can be used to treat carotid stenosis, but risks and benefits are uncertain. We therefore compared endovascular treatment with conventional carotid surgery. In a multicentre clinical trial, we randomly assigned 504 patients with carotid stenosis to endovascular treatment (n=251) or carotid endarterectomy (n=253). For endovascular patients treated successfully, we used stents in 55 (26%) and balloon angioplasty alone in 158 (74%). An independent neurologist followed up patients. Analysis was by intention to treat. The rates of major outcome events within 30 days of first treatment did not differ significantly between endovascular treatment and surgery (6.4% vs 5.9%, respectively, for disabling stroke or death; 10.0% vs 9.9% for any stroke lasting more than 7 days, or death). Cranial neuropathy was reported in 22 (8.7%) surgery patients, but not after endovascular treatment (p<0.0001). Major groin or neck haematoma occurred less often after endovascular treatment than after surgery (three [1.2%] vs 17 [6.7%], p<0.0015). At 1 year after treatment, severe (70-99%) ipsilateral carotid stenosis was more usual after endovascular treatment (25 [14%] vs seven [4%], p<0.001). However, no substantial difference in the rate of ipsilateral stroke was noted with survival analysis up to 3 years after randomisation (adjusted hazard ratio=1.04, 95% CI 0.63-1.70, p=0.9). Endovascular treatment had similar major risks and effectiveness at prevention of stroke during 3 years compared with carotid surgery, but with wide CIs. Endovascular treatment had the advantage of avoiding minor complications.
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                Author and article information

                Journal
                BMC Neurol
                BMC Neurol
                BMC Neurology
                BioMed Central
                1471-2377
                2012
                30 October 2012
                : 12
                : 127
                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
                Article
                1471-2377-12-127
                10.1186/1471-2377-12-127
                3557161
                23110412
                f8531863-0fe6-470e-a8f4-dbb4c5cc0e6e
                Copyright ©2012 Han et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 8 May 2011
                : 26 September 2012
                Categories
                Study Protocol

                Neurology
                Neurology

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