NCT01192581

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Brain Hypoperfusion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-04-01
• Completion: 2011-10-01
• First posted: 2010-09-01
• Last updated: 2010-11-01

Locations

1 site across 1 country: China