CASTRO-B - Study on CRP Apheresis in STROke Patients in Berlin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Selective Depletion of C-reactive Protein (CRP) With Therapeutic Apheresis (CRP Apheresis) in Stroke

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Device: CRP apheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Comparisons will be drawn from historic controls from previous observational stroke studies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRP apheresis<br>CRP apheresis by means of selective apheresis using the PentraSorb-CRP adsorber | Device: CRP apheresis<br>* selective CRP apheresis by use of the PentraSorb-CRP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct growth | Infarct growth measured via DWI-FLAIR volume change | 5 ± 1 days after infarction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct growth | Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change | 90 ± 14 days after infarction | 
| Stroke Severity | National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome | 5 ± 1 days after infarction | 
| Functional Outcome | Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales | 90 ± 14 days after infarction | 
| Dependency | Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales | 90 ± 14 days after infarction | 
| Cognitive Impairment | Montreal Cognitive Assessment (MoCA) - ranging from 0-30 with higher scores signifying better outcome; no subscales | 90 ± 14 days after infarction | 
| Quality of Life after Stroke via Stroke Impact Scale (SIS) | Stroke Impact Scale - Stroke Impact Scale (SIS) - measures different aspects of the overall impact of stroke on the patients' health and quality of life with different subscales addressing different domains: physical problems memory and thinking mood and emotions communication daily activities mobility motor impairment hand participation overall recovery higher values represent better outcome | 90 ± 14 days after infarction | 
| Incidence of Complications | Composite frequency of Complications within the time frame | 90 ± 14 days after infarction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke, CRP apheresis