Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 356
- 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). A 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, the investigator argues that DELP may exert neuroprotective effect on acute cerebral hemorrhage (ACH). In this context, the prospective, random, open-label, blind-endpoint, multi-centre study is designed.
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) with hematoma volume 5-40ml, or supratentorial lobar hemorrhages with hematoma volume 5-30ml;
- •NIHSS: 6-20;
- •Time from onset to DELP: 6-48 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, which should be treated by surgery;
- •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), or hypotension (systolic blood pressure below 90mmHg or diastolic blood pressure below 60 mmHg);
- •Previous allergy to heparin or calcium;
- •Life expectancy is less than 6 months due to comorbidity
- •Infected at the venipuncture site
- •hypoproteinemia;
- •Unsuitable for this clinical studies assessed by researcher.
研究组 & 干预措施
control group
DELP
Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration
干预措施: DELP (Device)
结局指标
主要结局
Proportion of patients with modified Rankin Score 0 to 2
时间窗: Day 90
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
次要结局
- Changes in National Institute of Health stroke scale (NIHSS)(24 hours and 2 weeks)
- the severe adverse events(24 hours)
- distribution of modified Rankin Score(Day 90)
- Proportion of patients with modified Rankin Score 0 to 1(Day 90)
- the occurence of stroke or other vascular events(Day 90)
- the changes in cerebral hematoma volume(24 hours)
- the occurence of death due to any cause(2 weeks)
研究者
Hui-Sheng Chen
Head of Neurology
General Hospital of Shenyang Military Region