Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion

Overview

The aim of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection, Vuloven) administrated intravenously for 7 days.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2011

Detailed Description

This study will recruit 120 male and female patients between 18 and 75 years of age who are diagnosed with brain hypoperfusion within the unilateral arteries branching from the internal carotid artery with or without cerebral infarction. All subjects are taking up to routine treatment medications. The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection, Vuloven) administrated intravenously for 7 days. Each patient who qualifies and chooses to participate in the study will be randomly assigned into treatment groups (consistent dose of hydroxyethyl starch 130/0.4 and sodium chloride injection of 500 ml/day, 1000 ml/day or 1500 ml/day) or control group (placebo control). The parameters of clinic visits will include a medical history, physical exam, clinical laboratory tests, magnetic resonance imaging (MRI), using T1-weighted scan, T2-weighted scan and diffusion-weighted imaging (DWI), digital subtraction angiography (DSA), and computed tomography (CT) perfusion.

Interventions

  • Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
    • routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
  • Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
    • routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
  • Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
    • routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg

Arms, Groups and Cohorts

  • No Intervention: control
    • routine treatment for brain hypoperfusion
  • Experimental: Vuloven1
    • routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
  • Experimental: Vuloven2
    • routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
  • Experimental: Vuloven3
    • routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy is evaluated based on the measure of CT perfusion parameters
    • Time Frame: 7 days
    • Efficacy is evaluated based on the measure of CT perfusion parameters

Secondary Measures

  • Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales
    • Time Frame: 7 days
    • Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales in those with cerebral infarction
  • Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection
    • Time Frame: 7 days
    • Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection was evaluated with the monitoring of adverse events (AEs), vital signs, and clinical laboratory data.

Participating in This Clinical Trial

Inclusion Criteria

1. The degree of the branching arteries stenosis from the internal carotid artery is greater or equal to 70% confirmed by DSA. 2. Before hydroxyethyl starch 130/0.4 and sodium chloride injection-additional treatment, CT perfusion shows that time to peak (TTP) in lesion area is more than that in corresponding area of contralateral hemisphere. 3. If cerebral infarction appears, the time course should be less than 48h, NIH stroke scale: 3-20, and MRI+DWI shows ischemic stroke due to large artery atherosclerosis. Exclusion Criteria:

1. Allergy to the components of Hydroxyethyl Starch 2. Chronic liver disease (ALT > 120 or AST > 120) 3. Chronic renal disease (Scr > 150 μmol/L) 4. Severe heart failure which correspond to NYHA heart failure classification class III or IV, or serious arrhythmia, myocardial infarction 5. Hemorrhagic stroke 6. Pregnant and lactating women 7. Patients suffered from epilepsy or mental sickness 8. Alcoholism or drug abuse 9. hydroxyethyl starch or other artificial colloidal solution was used within 3 months. 10. Patients participate in other clinical trial within 6 months 11. Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine >160 μmol/l) 12. Thrombus in lower limb vein

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xijing Hospital
  • Provider of Information About this Clinical Study
    • the neurology department of Xijing Hospital, Xijing Hospital
  • Overall Official(s)
    • Gang Zhao, MD, Study Director, the Department of Neurology , Xijing Hospital
    • Junliang Han, MD, Principal Investigator, Department of Neurology, Xijing Hospital
    • Fang Yang, MD, PhD, Principal Investigator, Department of Neurology , Xijing Hospital
  • Overall Contact(s)
    • Gang Zhao, MD, 86 029 84775361, zhaogang@fmmu.edu.cn

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