Selective depletion of C-reactive protein by therapeutic apheresis (CRP-apheresis) in ischemic stroke - CASTRO1
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3
研究概览
简要总结
The study was terminated due to insufficient recruitment. A total of three verum patients were recruited (2 male, 1 female). The mean age was 75 years. Plasma concentrations of CRP were reduced by a mean of 47.3% ± 11.6% by a total of eight CRP aphereses treatments. The mean treatment duration was 3 hours 49 minutes. The duration between onset of symptoms and first apheresis ranged from 43 to 71 hours. The initial CRP concentrations of the three patients were 15 mg/l, 21 mg/l, and 53 mg/l, respectively. CRP apheresis showed a very good safety profile in the treated patients and was well tolerated. Adverse events of CRP apheresis did not occur. Data analyses on the endpoints were not performed due to the small number of patients included. Consequently, statements on the clinical relevance of the data cannot be derived.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Ischaemic stroke with determination of infarct size by imaging,
- •NIHSS 1-24,
- •CRP increase = 5 mg/l within presumably 72 hours after stroke and/or CRP value above 10 mg/l,
- •Legal capacity,
- •Written informed consent of the patient or a legal representative
排除标准
- •Severe dysphagia (danger of aspiration pneumonia),
- •Clinical or laboratory evidence of a severe systemic infection,
- •Participation in another interventional study,
- •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