Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP-apheresis) in Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety of CRP apheresis
研究概览
简要总结
CASTRO1 is a study to investigate the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP-apheresis) in patients after primary treatment of ischemic stroke.
The term therapeutic apheresis commonly refers to medical procedures, where pathogenic constituents are being removed from the circulating blood. Elimination is performed by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood (circulation) to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient.
The adsorber "PentraSorb® CRP" used for CRP apheresis is CE-certified. It is designated to the selective depletion of C-reactive protein from human blood.
详细描述
The purpose of the study is to evaluate the safety and efficacy of CRP apheresis in patients following ischemic stroke. CRP apheresis is to be conducted with the aim of reducing cerebral damage following the guideline-appropriate primary therapy of ischemic stroke.
A possible protective effect of CRP apheresis will be assessed by clinical scores, laboratory determination of immunologic parameters and determination of the size of the infarct area by magnetic resonance imaging (MRI).
The study will be randomized, controlled and monocentric.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischaemic stroke with determination of infarct size by imaging (MRI)
- •NIHSS 1-24
- •CRP increase ≥ 5 mg/l within presumed 72 hours after stroke and/or CRP value > 10 mg/l
- •written informed consent of the patient or his legal representative
排除标准
- •age < 18 years
- •Severe dysphagia (danger of aspiration pneumonia)
- •Clinical or laboratory evidence of a severe systemic infection
- •Participation in other interventional studies
- •Contraindications against apheresis therapy
- •Modified Rankin Scale (mRS) before index event ≥ 3
- •Intracranial hemorrhage
- •Epileptic seizure in the context of the acute event
- •Pregnancy, lactation
结局指标
主要结局
Safety of CRP apheresis
时间窗: 24 hours after each apheresis
Incidence of expected and unexpected adverse effects
次要结局
- Concentration of inflammatory biomarkers (CRP, IL-6, SAA)(0-7 days after infarction)
- Stroke Severity(before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction)
- Infarct size(6 ± 3 days after infarction and 12 ± 2 weeks after infarction)
- Functional Outcome(before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction)
- Dependency(6 ± 3 days after infarction and 12 ± 2 weeks after infarction)