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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT03884153
Collaborator
NeuroCure Clinical Research Center, Charite, Berlin (Other), Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin (Other)
20
Enrollment
1
Location
1
Arm
24.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CRP apheresis
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Comparisons will be drawn from historic controls from previous observational stroke studiesComparisons will be drawn from historic controls from previous observational stroke studies
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Selective Depletion of C-reactive Protein (CRP) With Therapeutic Apheresis (CRP Apheresis) in Stroke
Actual Study Start Date :
Dec 3, 2020
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Infarct growth [5 ± 1 days after infarction]

    Infarct growth measured via DWI-FLAIR volume change

Secondary Outcome Measures

  1. Infarct growth [90 ± 14 days after infarction]

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

  2. 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

  3. Functional Outcome [90 ± 14 days after infarction]

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

  4. Dependency [90 ± 14 days after infarction]

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

  5. Cognitive Impairment [90 ± 14 days after infarction]

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

  6. 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

  7. Incidence of Complications [90 ± 14 days after infarction]

    Composite frequency of Complications within the time frame

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité Berlin Germany 12200

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT03884153
Other Study ID Numbers:
  • CASTRO-B
First Posted:
Mar 21, 2019
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
Ischemic Stroke
CRP apheresis
Additional relevant MeSH terms:
Stroke
Ischemic Stroke

Study Results

No Results Posted as of Mar 25, 2022