Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy is evaluated based on the measure of CT perfusion parameters
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Vuloven1
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
干预措施: hydroxyethyl starch 130/0.4 and sodium chloride injection (Drug)
Vuloven2
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
干预措施: hydroxyethyl starch 130/0.4 and sodium chloride injection (Drug)
Vuloven3
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg
干预措施: hydroxyethyl starch 130/0.4 and sodium chloride injection (Drug)
结局指标
主要结局
Efficacy is evaluated based on the measure of CT perfusion parameters
时间窗: 7 days
Efficacy is evaluated based on the measure of CT perfusion parameters
次要结局
- Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales(7 days)
- Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection(7 days)