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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: CRP apheresis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12200
    • Recruiting
    • Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRP apheresis; CRP apheresis by means of selective apheresis using the "PentraSorb"-CRP adsorber	Device: CRP apheresis; selective CRP apheresis by use of the "PentraSorb"-CRP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: NeuroCure Clinical Research Center, Charite, Berlin; Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Ischemic Stroke; CRP apheresis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CASTRO-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No