Clinical trial NCT01192581: Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion
Official title: Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain Hypoperfusion
Keywords: brain hypoperfusion
Vuloven
computed tomography perfusion
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Efficacy is evaluated based on the measure of CT perfusion parameters
timeFrame: 7 days
Secondary outcomes:
measure: Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales
timeFrame: 7 days
measure: Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection
timeFrame: 7 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Neurology , Xijing Hospital
state: Shaanxi
Study officials:
affiliation: the Department of Neurology , Xijing Hospital
name: Gang Zhao, MD
role: STUDY_DIRECTOR
affiliation: Department of Neurology, Xijing Hospital
name: Junliang Han, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology , Xijing Hospital
name: Fang Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han J, Yang F, Jiang W, Zhang G, Liu Z, Liu X, Xia F, Bai Y, He J, Chao M, Zhao G. Hydroxyethyl starch 130/0.4 and sodium chloride injection as adjunctive therapy in patients with cerebral hypoperfusion. BMC Neurol. 2012 Oct 30;12:127. doi: 10.1186/1471-2377-12-127.