Selective depletion of C-reactive protein by therapeutic apheresis (CRP-apheresis) in ischemic stroke
- Conditions
- I63Cerebral infarction
- Registration Number
- DRKS00021102
- Lead Sponsor
- Pentracor GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 3
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
Age < 18,
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of CRP apheresis: Incidence of expected and unexpected adverse effects
- Secondary Outcome Measures
Name Time Method IHSS score (National Institute of Health Stroke Scale) <br>mRS (modified Rankin Scale) <br>BI (Barthel Index) <br>Infarct size (MRT volume change)<br>The infarct size is determined by 2 additional MRIs 6 ± 3 days and 12 ± 2 weeks after the infarct, the scores at the same time.<br>Biomarker of inflammation (CRP, interleukin-6 and serum amyloid A) are determined twice daily until discharge of the patient, but not more than 7 days after onset of symptoms.<br><br>