Efficacy and Safety of Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- modified Rankin Scale
研究概览
简要总结
Intracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator. It has been widely used in autoimmune disease and has also been testified effective in ICH who received conservative treatment. The present study aims to evaluate the efficiency and safety of fingolimod for ICH with minimal invasive treatment.
详细描述
40 ICH patients who meet the inclusion criteria will be enrolled in the present study.
All ICH patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review.
After obtaining written consent from the family, patients randomly assigned to the fingolimod group will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days. Patients assigned to the control group will not receive fingolimod. All patients will receive minimal invasive puncture and drainage of hematoma. The investigators will evaluate the neurofunctional before and 30 days, 90 days and 180 days after oral fingolimod. CT scan will be performed at before, 7 and 14 days after oral fingolimod. 5ml intravenous blood for flow cytometry is also taken before and 1day, 3days, 7days after fingolimod use.
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
- •spontaneous basal ganglia ICH with volume larger than 20ml;
- •age: 18-80 years;
- •admission Glasgow Coma Scale score: 5-12;
- •admitting to hospital with 24 hours after injury;
- •no fever or signs infection on admission to hospital;
- •admission heart rate≥60/min on admission.
排除标准
- •refuse follow-up;
- •received operation before admitting to hospital;
- •hemorrhage by tumor, arteriovenous malformation, arterial aneurysm, hematological disease or traumatic brain injury;
- •severe vomiting;
- •mRS>1 before ICH;
- •prior history of bradycardia;
- •prior history of Atrioventricular block;
- •prior history of traumatic brain injury, craniotomy or stroke;
- •expected lifetime less than 1 year;
- •undergoing antitumor, antiepileptic, immunomodulatory or immunosuppressive therapy;
- •admitting to other ongoing study;
- •systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence;
- •received anticoagulant or antiplatelet therapy within 7 days;
- •intraventricular hemorrhage requires intraventricular catheterization.
研究组 & 干预措施
Fingolimod group
0.5mg/day oral fingolimod over a course of 3 consecutive days
干预措施: Fingolimod (Drug)
结局指标
主要结局
modified Rankin Scale
时间窗: 90 days and 180 days after ICH
Neurological outcome, range: 0-6. The higher scores mean a worse outcome.
次要结局
- The National Institutes of Health Stroke Scale(90 days and 180 days after ICH)
- Montreal Cognitive Assessment Scale(90 days and 180 days after ICH)
- Modified Barthel Index(90 days and 180 days after ICH)
- Volume of perihematomal edema(Baseline on admission, 7 days and 14 days after ICH)