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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884153
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : December 9, 2019
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

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
Stroke, Ischemic Device: CRP apheresis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Selective Depletion of C-reactive Protein (CRP) With Therapeutic Apheresis (CRP Apheresis) in Stroke
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : August 31, 2021

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




Primary Outcome Measures :
  1. Infarct growth [ Time Frame: 5 ± 1 days after infarction ]
    Infarct growth measured via DWI-FLAIR volume change


Secondary Outcome Measures :
  1. Infarct growth [ Time Frame: 90 ± 14 days after infarction ]
    Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change

  2. 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

  3. 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

  4. Dependency [ Time Frame: 90 ± 14 days after infarction ]
    Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales

  5. 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

  6. 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

  7. Incidence of Complications [ Time Frame: 90 ± 14 days after infarction ]
    Composite frequency of Complications within the time frame



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884153


Contacts
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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

Locations
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Germany
NeuroCure Clinical Research Center (NCRC), Charité
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
Investigators
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Principal Investigator: Andreas Meisel, Prof. Dr. med. Charite University, Berlin, Germany

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Responsible Party: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03884153    
Other Study ID Numbers: CASTRO-B
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
Ischemic Stroke
CRP apheresis
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases