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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | routine treatment for brain hypoperfusion | |
| Vuloven1 | Experimental | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg |
|
| Vuloven2 | Experimental | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg |
|
| Vuloven3 | Experimental | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydroxyethyl starch 130/0.4 and sodium chloride injection | Drug | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy is evaluated based on the measure of CT perfusion parameters | Efficacy is evaluated based on the measure of CT perfusion parameters | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales | Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales in those with cerebral infarction | 7 days |
| Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Zhao, MD | Contact | 86 029 84775361 | zhaogang@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao, MD | the Department of Neurology , Xijing Hospital | Study Director |
| Junliang Han, MD | Department of Neurology, Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology , Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23110412 | Derived | 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. |
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| hydroxyethyl starch 130/0.4 and sodium chloride injection | Drug | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg |
|
| hydroxyethyl starch 130/0.4 and sodium chloride injection | Drug | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg |
|
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. |
| 7 days |
| Fang Yang, MD, PhD |
| Department of Neurology , Xijing Hospital |
| Principal Investigator |
| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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