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

Phase 2

• Conditions: Brain Hypoperfusion
• Interventions: Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

• Registration Number: NCT01192581
• Lead Sponsor: Xijing Hospital

Brief 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.

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-08
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-09-01
• Last Update Submitted: 2010-10-28
• Last Update Posted: 2010-11-01
• Primary Completion: 2011-04
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vuloven1	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
Vuloven3	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
Vuloven2	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

Primary Outcome Measures

Name	Time	Method
Efficacy is evaluated based on the measure of CT perfusion parameters	7 days	Efficacy is evaluated based on the measure of CT perfusion parameters

Secondary Outcome Measures

Name	Time	Method
Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales	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	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.

Trial Locations

Locations (1)

Department of Neurology , Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China