Status:
UNKNOWN
Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion
Lead Sponsor:
Xijing Hospital
Conditions:
Brain Hypoperfusion
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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) administrat...
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...
Eligibility Criteria
Inclusion
- The degree of the branching arteries stenosis from the internal carotid artery is greater or equal to 70% confirmed by DSA.
- 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.
- 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
- Allergy to the components of Hydroxyethyl Starch
- Chronic liver disease (ALT \> 120 or AST \> 120)
- Chronic renal disease (Scr \> 150 μmol/L)
- Severe heart failure which correspond to NYHA heart failure classification class III or IV, or serious arrhythmia, myocardial infarction
- Hemorrhagic stroke
- Pregnant and lactating women
- Patients suffered from epilepsy or mental sickness
- Alcoholism or drug abuse
- hydroxyethyl starch or other artificial colloidal solution was used within 3 months.
- Patients participate in other clinical trial within 6 months
- Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine \>160 μmol/l)
- Thrombus in lower limb vein
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01192581
Start Date
August 1 2010
End Date
October 1 2011
Last Update
November 1 2010
Active Locations (1)
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1
Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, China, 710032