Stroke, IschemicCASTRO-BNCT03884153
CASTRO-B - Study on CRP Apheresis in STROke Patients in Berlin
A study testing CRP apheresis in people with Stroke, Ischemic, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- CRP apheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 3 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité
Berlin, 12200
Andreas Meisel, Prof. Dr. med., +49 30 450 560026, andreas.meisel@charite.de
Benjamin Hotter, Dr. med., +49 30 450 639 729, benjamin.hotter@charite.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Ischemic
- Being tested
- CRP apheresis
- Keywords
- Ischemic Stroke, CRP apheresis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP apheresisDevice
selective CRP apheresis by use of the "PentraSorb"-CRP
| Study group | Role | What they receive |
|---|---|---|
| CRP apheresis | Experimental | CRP apheresis by means of selective apheresis using the "PentraSorb"-CRP adsorber Receives: Device: CRP apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct growth
Infarct growth measured via DWI-FLAIR volume change
Measured: 5 ± 1 days after infarction
Secondary outcomes (7)
Infarct growth
Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
Measured: 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
Measured: 5 ± 1 days after infarction
Functional Outcome
Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales
Measured: 90 ± 14 days after infarction
Dependency
Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales
Measured: 90 ± 14 days after infarction
Cognitive Impairment
Montreal Cognitive Assessment (MoCA) - ranging from 0-30 with higher scores signifying better outcome; no subscales
Measured: 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
Measured: 90 ± 14 days after infarction
Incidence of Complications
Composite frequency of Complications within the time frame
Measured: 90 ± 14 days after infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start3 Dec 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparisons will be drawn from historic controls from previous observational stroke studies
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin, Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, Prof. Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884153
- Sponsor's protocol ID
- CASTRO-B
- Acronym
- CASTRO-B
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Depletion of C-reactive Protein (CRP) With Therapeutic Apheresis (CRP Apheresis) in Stroke
- ClinicalTrials.gov ID
- NCT03884153
- Acronym / sponsor ID
- CASTRO-B / CASTRO-B
- Conditions
- Stroke, Ischemic
- Keywords
- Ischemic Stroke, CRP apheresis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin, Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparisons will be drawn from historic controls from previous observational stroke studies
| Arm | Type | Receives |
|---|---|---|
| CRP apheresis | Experimental | Device: CRP apheresisCRP apheresis by means of selective apheresis using the "PentraSorb"-CRP adsorber |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRP apheresisselective CRP apheresis by use of the "PentraSorb"-CRP | Device | CRP apheresis |
Primary outcome
Infarct growth
Time frame: 5 ± 1 days after infarction
Infarct growth measured via DWI-FLAIR volume change
7 secondary outcomes
Infarct growth
Time frame: 90 ± 14 days after infarction
Stroke Severity
Time frame: 5 ± 1 days after infarction
Functional Outcome
Time frame: 90 ± 14 days after infarction
Dependency
Time frame: 90 ± 14 days after infarction
Cognitive Impairment
Time frame: 90 ± 14 days after infarction
Quality of Life after Stroke via Stroke Impact Scale (SIS)
Time frame: 90 ± 14 days after infarction
Incidence of Complications
Time frame: 90 ± 14 days after infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, Prof. Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP apheresis in people with Stroke, Ischemic, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Hotter, Dr. med. (+49 30 450 639729, benjamin.hotter@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct growth (time frame: 5 ± 1 days after infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.