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

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ClinicalTrials.gov Identifier: NCT03884153
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : June 29, 2020
Sponsor:
Collaborators:
NeuroCure Clinical Research Center, Charite, Berlin
Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE March 19, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date June 29, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
Infarct growth [ Time Frame: 5 ± 1 days after infarction ]
Infarct growth measured via DWI-FLAIR volume change
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Infarct growth [ Time Frame: 90 ± 14 days after infarction ]
    Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
  • Stroke Severity [ Time Frame: 5 ± 1 days after infarction ]
    National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome
  • Functional Outcome [ Time Frame: 90 ± 14 days after infarction ]
    Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales
  • Dependency [ Time Frame: 90 ± 14 days after infarction ]
    Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales
  • Cognitive Impairment [ Time Frame: 90 ± 14 days after infarction ]
    Montreal Cognitive Assessment (MoCA) - ranging from 0-30 with higher scores signifying better outcome; no subscales
  • Quality of Life after Stroke via Stroke Impact Scale (SIS) [ Time Frame: 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
  • Incidence of Complications [ Time Frame: 90 ± 14 days after infarction ]
    Composite frequency of Complications within the time frame
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Infarct growth [ Time Frame: 90 ± 14 days after infarction ]
    Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
  • Stroke Severity [ Time Frame: 5 ± 1 days after infarction ]
    NIHSS score
  • Functional Outcome [ Time Frame: 90 ± 14 days after infarction ]
    Modified ranking scale (mRS) score
  • Dependency [ Time Frame: 90 ± 14 days after infarction ]
    Barthels Index
  • Cognitive Impairment [ Time Frame: 90 ± 14 days after infarction ]
    Montreal Cognitive Assessment (MoCA)
  • Quality of Life after Stroke via Stroke Impact Scale (SIS) [ Time Frame: 90 ± 14 days after infarction ]
    Stroke Impact Scale
  • Incidence of Complications [ Time Frame: 90 ± 14 days after infarction ]
    Composite frequency of Complications within the time frame
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CASTRO-B - Study on CRP Apheresis in STROke Patients in Berlin
Official Title  ICMJE Selective Depletion of C-reactive Protein (CRP) With Therapeutic Apheresis (CRP Apheresis) in Stroke
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Comparisons will be drawn from historic controls from previous observational stroke studies
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke, Ischemic
Intervention  ICMJE Device: CRP apheresis
selective CRP apheresis by use of the "PentraSorb"-CRP
Study Arms  ICMJE Experimental: CRP apheresis
CRP apheresis by means of selective apheresis using the "PentraSorb"-CRP adsorber
Intervention: Device: CRP apheresis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Benjamin Hotter, Dr. med. +49 30 450 639729 benjamin.hotter@charite.de
Contact: Andreas Meisel, Prof. Dr. med. +49 30 450 560026 andreas.meisel@charite.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03884153
Other Study ID Numbers  ICMJE CASTRO-B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andreas Meisel, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE
  • NeuroCure Clinical Research Center, Charite, Berlin
  • Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
Investigators  ICMJE
Principal Investigator: Andreas Meisel, Prof. Dr. med. Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP