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

• Status: Unknown status
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

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