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

Stroke, Ischemic Clinical Trial

— CASTRO-B  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03884153
• Other study ID #: CASTRO-B
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Charite University, Berlin, Germany
• Contact: Benjamin Hotter, Dr. med.
• Phone: +49 30 450 639729
• Email: benjamin.hotter[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Device:
• CRP apheresis
selective CRP apheresis by use of the "PentraSorb"-CRP

Locations

Country	Name	City	State
Germany	Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin, NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct growth	Infarct growth measured via DWI-FLAIR volume change	5 ± 1 days after infarction
Secondary	Infarct growth	Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change	90 ± 14 days after infarction
Secondary	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
Secondary	Functional Outcome	Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales	90 ± 14 days after infarction
Secondary	Dependency	Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales	90 ± 14 days after infarction
Secondary	Cognitive Impairment	Montreal Cognitive Assessment (MoCA) - ranging from 0-30 with higher scores signifying better outcome; no subscales	90 ± 14 days after infarction
Secondary	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
Secondary	Incidence of Complications	Composite frequency of Complications within the time frame	90 ± 14 days after infarction