Stroke, Ischemic
Conditions
Keywords
Ischemic Stroke, CRP apheresis
Brief summary
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
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.
Interventions
DEVICECRP apheresis
selective CRP apheresis by use of the PentraSorb-CRP
Sponsors
NeuroCure Clinical Research Center, Charite, Berlin
Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
Charite University, Berlin, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparisons will be drawn from historic controls from previous observational stroke studies
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct growth | 5 ± 1 days after infarction | Infarct growth measured via DWI-FLAIR volume change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Severity | 5 ± 1 days after infarction | National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome |
| Functional Outcome | 90 ± 14 days after infarction | Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales |
| Dependency | 90 ± 14 days after infarction | Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales |
| Infarct growth | 90 ± 14 days after infarction | Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change |
| Quality of Life after Stroke via Stroke Impact Scale (SIS) | 90 ± 14 days after infarction | 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 |
| Incidence of Complications | 90 ± 14 days after infarction | Composite frequency of Complications within the time frame |
| Cognitive Impairment | 90 ± 14 days after infarction | Montreal Cognitive Assessment (MoCA) - ranging from 0-30 with higher scores signifying better outcome; no subscales |
Countries
Germany
Contacts
Primary ContactBenjamin Hotter, Dr. med.
Backup ContactAndreas Meisel, Prof. Dr. med.
Outcome results
None listed