Overview

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