Selective Depletion of C-reactive Protein (CRP) With Therapeutic Apheresis (CRP Apheresis) in Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Infarct growth
研究概览
简要总结
This study explores the use of CRP level reduction in patients after suffering from acute ischemic stroke. Using selective CRP-apheresis, the investigators aim to reduce the secondary inflammatory tissue damage in the course of infarction maturation using infarction growth in MRI as the primary outcome as a surrogate.
详细描述
C-reactive protein (CRP) is an acute-phase protein binding to phosphocholine, thereby marking damaged tissue. This in turn activates the complement system and the cellular immune system engaging the unspecific immune system in an inflammatory tissue-degrading reaction. Such a pattern is observed in ischemic stroke, and elevated CRP levels can be measured in stroke survivors' sera. Several observational studies reproduced higher CRP levels with negative outcome in stroke. In another vascular model disease, myocardial infarction, selective CRP apheresis reduced infarct size in humans. The investigators therefore designed this pilot study to explore the effects of selective CRP reduction in ischemic stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 85 years
- •Informed consent signed by patient
- •Patients with acute ischemic stroke in the Arteria cerebri media (MCA) territory within 36 hours of event
- •Acute MRI with evidence of infarction
- •NIHSS ≥ 4
- •CRP > 5 mg/l
排除标准
- •Withdrawal of consent
- •Systolic blood pressure <100 mmHg before the apheresis
- •Blood pressure relevant extra- and intracranial stenoses (NASCET 70)
- •Apheresis contraindication
- •Participation in other interventional studies
结局指标
主要结局
Infarct growth
时间窗: 5 ± 1 days after infarction
Infarct growth measured via DWI-FLAIR volume change
次要结局
- Infarct growth(90 ± 14 days after infarction)
- Functional Outcome(90 ± 14 days after infarction)
- Quality of Life after Stroke via Stroke Impact Scale (SIS)(90 ± 14 days after infarction)
- Incidence of Complications(90 ± 14 days after infarction)
- Stroke Severity(5 ± 1 days after infarction)
- Dependency(90 ± 14 days after infarction)
- Cognitive Impairment(90 ± 14 days after infarction)
研究者
Andreas Meisel
Prof. Dr. med.
Charite University, Berlin, Germany