NCT04708990终止2 期
DELP for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Single Centre, Pilot Study
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年1月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of patients with modified Rankin Score 0 to 2
研究概览
简要总结
Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). Our recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, we argue that DELP may exert neuroprotective effect on acute cerebral hemorrhage.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80;
- •Spontaneous cerebral hemorrhage;
- •Deep supratentorial intracerebral hemorrhage (basal ganglia and thalamus) with hematoma volume 5-40ml;
- •NIHSS: 4-22;
- •Time from onset to DELP is less than 48 hours;
- •Premorbid mRS 0 or 1;
- •Signed informed consent;
排除标准
- •Secondary cerebral hemorrhage (secondary to trauma, tumor, vascular malformation, hemorrhage transformation of ischemic stroke, etc.);
- •Comatose patients on admission (GCS score 3-8 on the Glasgow Coma Scale);
- •Patients with intracerebral hemorrhage ruptured into the ventricle;
- •Planed surgery;
- •Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- •Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- •Previous allergy to heparin or calcium;
- •hypoproteinemia;
- •Unsuitable for this clinical studies assessed by researcher.
结局指标
主要结局
Proportion of patients with modified Rankin Score 0 to 2
时间窗: Day 90
次要结局
- Proportion of patients with modified Rankin Score 0 to 1(Day 90)
- Changes in national institutes of health stroke scale (NIHSS)(48 hours)
- changes of hematoma volume compared with the baseline(48 hours)
- changes of edema volume around hematoma compared with the baseline(48 hours)
- the occurence of death due to any cause(Day 90)
研究者
Hui-Sheng Chen
Head of Neurology
General Hospital of Shenyang Military Region
研究点 (1)
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