Clinical trial NCT03884153: CASTRO-B - Study on CRP Apheresis in STROke Patients in Berlin
Official title: Selective Depletion of C-reactive Protein (CRP) With Therapeutic Apheresis (CRP Apheresis) in Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Ischemic Stroke
CRP apheresis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: NeuroCure Clinical Research Center, Charite, Berlin
name: Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
First posted: 2019-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparisons will be drawn from historic controls from previous observational stroke studies
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infarct growth
timeFrame: 5 ± 1 days after infarction
Secondary outcomes:
measure: Infarct growth
timeFrame: 90 ± 14 days after infarction
measure: Stroke Severity
timeFrame: 5 ± 1 days after infarction
measure: Functional Outcome
timeFrame: 90 ± 14 days after infarction
measure: Dependency
timeFrame: 90 ± 14 days after infarction
measure: Cognitive Impairment
timeFrame: 90 ± 14 days after infarction
measure: Quality of Life after Stroke via Stroke Impact Scale (SIS)
timeFrame: 90 ± 14 days after infarction
measure: Incidence of Complications
timeFrame: 90 ± 14 days after infarction
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Meisel, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: