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

Charite University, Berlin, Germany20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke, Ischemic

Interventions

CRP apheresisDEVICE

selective CRP apheresis by use of the "PentraSorb"-CRP

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

Infarct growth

Infarct growth measured via DWI-FLAIR volume change

Time frame: 5 ± 1 days after infarction

Secondary Outcomes

Infarct growth

Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change

Time frame: 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

Time frame: 5 ± 1 days after infarction

Functional Outcome

Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales

Time frame: 90 ± 14 days after infarction

Dependency

Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales

Time frame: 90 ± 14 days after infarction

Cognitive Impairment

Montreal Cognitive Assessment (MoCA) - ranging from 0-30 with higher scores signifying better outcome; no subscales

Time frame: 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

Central Contacts

Benjamin Hotter, Dr. med.

CONTACT

+49 30 450 639729 benjamin.hotter@charite.de

Andreas Meisel, Prof. Dr. med.

CONTACT

+49 30 450 560026 andreas.meisel@charite.de

Data from ClinicalTrials.gov

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