Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: control routine treatment for brain hypoperfusion |
|
| Experimental: Vuloven1 routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg |
Drug: 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
|
| Experimental: Vuloven2 routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg |
Drug: 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
|
| Experimental: Vuloven3 routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg |
Drug: 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology , Xijing Hospital | Xi'an | Shaanxi | China | 710032 |
Sponsors and Collaborators
- Xijing Hospital
Investigators
- Study Director: Gang Zhao, MD, the Department of Neurology , Xijing Hospital
- Principal Investigator: Junliang Han, MD, Department of Neurology, Xijing Hospital
- Principal Investigator: Fang Yang, MD, PhD, Department of Neurology , Xijing Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Vuloven001