Back to resultsCASTRO-B - Study on CRP Apheresis in STROke Patients in Berlin (CASTRO-B)
Primary Purpose
Stroke, Ischemic
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CRP apheresis
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic focused on measuring Ischemic Stroke, CRP apheresis
Eligibility 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
Sites / Locations
- Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der CharitéRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRP apheresis
Arm Description
CRP apheresis by means of selective apheresis using the "PentraSorb"-CRP adsorber
Outcomes
Primary Outcome Measures
Infarct growth
Infarct growth measured via DWI-FLAIR volume change
Secondary Outcome Measures
Infarct growth
Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
Stroke Severity
National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome
Functional Outcome
Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales
Dependency
Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales
Cognitive Impairment
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)
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
Composite frequency of Complications within the time frame
Full Information
NCT ID
NCT03884153
First Posted
March 19, 2019
Last Updated
March 24, 2022
Sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin, Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
1. Study Identification
Unique Protocol Identification Number
NCT03884153
Brief Title
CASTRO-B - Study on CRP Apheresis in STROke Patients in Berlin
Acronym
CASTRO-B
Official Title
Selective Depletion of C-reactive Protein (CRP) With Therapeutic Apheresis (CRP Apheresis) in Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin, Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Ischemic Stroke, CRP apheresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Comparisons will be drawn from historic controls from previous observational stroke studies
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRP apheresis
Arm Type
Experimental
Arm Description
CRP apheresis by means of selective apheresis using the "PentraSorb"-CRP adsorber
Intervention Type
Device
Intervention Name(s)
CRP apheresis
Intervention Description
selective CRP apheresis by use of the "PentraSorb"-CRP
Primary Outcome Measure Information:
Title
Infarct growth
Description
Infarct growth measured via DWI-FLAIR volume change
Time Frame
5 ± 1 days after infarction
Secondary Outcome Measure Information:
Title
Infarct growth
Description
Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
Time Frame
90 ± 14 days after infarction
Title
Stroke Severity
Description
National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome
Time Frame
5 ± 1 days after infarction
Title
Functional Outcome
Description
Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales
Time Frame
90 ± 14 days after infarction
Title
Dependency
Description
Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales
Time Frame
90 ± 14 days after infarction
Title
Cognitive Impairment
Description
Montreal Cognitive Assessment (MoCA) - ranging from 0-30 with higher scores signifying better outcome; no subscales
Time Frame
90 ± 14 days after infarction
Title
Quality of Life after Stroke via Stroke Impact Scale (SIS)
Description
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
Time Frame
90 ± 14 days after infarction
Title
Incidence of Complications
Description
Composite frequency of Complications within the time frame
Time Frame
90 ± 14 days after infarction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Hotter, Dr. med.
Phone
+49 30 450 639729
Email
benjamin.hotter@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Meisel, Prof. Dr. med.
Phone
+49 30 450 560026
Email
andreas.meisel@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Meisel, Prof. Dr. med.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Meisel, Prof. Dr. med.
Phone
+49 30 450 560026
Email
andreas.meisel@charite.de
First Name & Middle Initial & Last Name & Degree
Benjamin Hotter, Dr. med.
Phone
+49 30 450 639 729
Email
benjamin.hotter@charite.de
12. IPD Sharing Statement
Learn more about this trial
CASTRO-B - Study on CRP Apheresis in STROke Patients in Berlin
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