Stroke, IschemicCASTRO1NCT04417231
CASTRO1 - Study on CRP Apheresis After Ischemic Stroke
A study testing CRP apheresis in people with Stroke, Ischemic, run by Pentracor GmbH at 1 site in Germany.
Trial summary
CASTRO1 is a study to investigate the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP-apheresis) in patients after primary treatment of ischemic stroke. The term therapeutic apheresis commonly refers to medical procedures, where pathogenic constituents are being removed from the circulating blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 3 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jan 2021to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischaemic stroke with determination of infarct size by imaging (MRI)
- NIHSS 1-24
- CRP increase ≥ 5 mg/l within presumed 72 hours after stroke and/or CRP value > 10 mg/l
- written informed consent of the patient or his legal representative
Who cannot join
- age < 18 years
- Severe dysphagia (danger of aspiration pneumonia)
- Clinical or laboratory evidence of a severe systemic infection
- Participation in other interventional studies
- Contraindications against apheresis therapy
- Modified Rankin Scale (mRS) before index event ≥ 3
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- Intracranial hemorrhage
- Epileptic seizure in the context of the acute event
- Pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP-apheresis) in Ischemic Stroke
CASTRO1 is a study to investigate the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP-apheresis) in patients after primary treatment of ischemic stroke.
The term therapeutic apheresis commonly refers to medical procedures, where pathogenic constituents are being removed from the circulating blood. Elimination is performed by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood (circulation) to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient.
The adsorber "PentraSorb® CRP" used for CRP apheresis is CE-certified. It is designated to the selective depletion of C-reactive protein from human blood.
Read the detailed description
The purpose of the study is to evaluate the safety and efficacy of CRP apheresis in patients following ischemic stroke. CRP apheresis is to be conducted with the aim of reducing cerebral damage following the guideline-appropriate primary therapy of ischemic stroke.
A possible protective effect of CRP apheresis will be assessed by clinical scores, laboratory determination of immunologic parameters and determination of the size of the infarct area by magnetic resonance imaging (MRI).
The study will be randomized, controlled and monocentric.
- Conditions
- Stroke, Ischemic
- Being tested
- 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 |
|---|---|---|
| Apheresis group | Experimental | 10 patients receive a maximum of 3 apheresis treatments at intervals of 24 ± 12 hours each (from the beginning of the preceding treatment). The first treatment starts within 72 hours after infarction or, in case of an unclear time window, within presumed 72 hours after the patient was last seen free of symptoms. No further treatments are carried out if the CRP concentration before the start of a treatment is <10 mg/l or if the patient has been discharged from hospital.
For each treatment, 1.5 - 2.5 times the plasma volume is processed. The duration of each treatment is approximately 4-6 hours. Receives: Device: CRP apheresis |
| Control group | No intervention | 10 patients of the control group receive the same examinations as arm 1 (verum group) but no apheresis treatments after ischemic stroke. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CRP apheresis
Incidence of expected and unexpected adverse effects
Measured: 24 hours after each apheresis
Secondary outcomes (5)
Stroke Severity
National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome
Measured: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Functional Outcome
Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome
Measured: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Dependency
Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome
Measured: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Infarct size
Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
Measured: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Concentration of inflammatory biomarkers (CRP, IL-6, SAA)
CRP, Interleukin-6, and serum amyloid A are determined twice daily until discharge of the patient (for a maximum of 7 days).
Measured: 0-7 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 posted4 Jun 2020
- Study start28 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: sufficient recruitment of study patients based on the existing (and repeatedly adjusted) inclusion and exclusion criteria is not possible within a reasonable period of time
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pentracor GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Dorst, PD Dr. med., Principal investigator, Universitätsklinik Ulm, Abteilung für Neurologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417231
- Sponsor's protocol ID
- P-05 CASTRO1
- Acronym
- CASTRO1
- Status last verified
- Jan 2023
- First submitted
- 29 May 2020
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP-apheresis) in Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04417231
- Acronym / sponsor ID
- CASTRO1 / P-05 CASTRO1
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sufficient recruitment of study patients based on the existing (and repeatedly adjusted) inclusion and exclusion criteria is not possible within a reasonable period of time
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Pentracor GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Jun 2020 (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.
CASTRO1 is a study to investigate the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP-apheresis) in patients after primary treatment of ischemic stroke.
The term therapeutic apheresis commonly refers to medical procedures, where pathogenic constituents are being removed from the circulating blood. Elimination is performed by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood (circulation) to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient.
The adsorber "PentraSorb® CRP" used for CRP apheresis is CE-certified. It is designated to the selective depletion of C-reactive protein from human blood.
Detailed description
The purpose of the study is to evaluate the safety and efficacy of CRP apheresis in patients following ischemic stroke. CRP apheresis is to be conducted with the aim of reducing cerebral damage following the guideline-appropriate primary therapy of ischemic stroke.
A possible protective effect of CRP apheresis will be assessed by clinical scores, laboratory determination of immunologic parameters and determination of the size of the infarct area by magnetic resonance imaging (MRI).
The study will be randomized, controlled and monocentric.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apheresis group | Experimental | Device: CRP apheresis10 patients receive a maximum of 3 apheresis treatments at intervals of 24 ± 12 hours each (from the beginning of the preceding treatment). The first treatment starts within 72 hours after infarction or, in case of an unclear time window, within presumed 72 hours after the patient was last seen free of symptoms. No further treatments are carried out if the CRP concentration before the start of a treatment is <10 mg/l or if the patient has been discharged from hospital. For each treatment, 1.5 - 2.5 times the plasma volume is processed. The duration of each treatment is approximately 4-6 hours. |
| Control group | No intervention | –10 patients of the control group receive the same examinations as arm 1 (verum group) but no apheresis treatments after ischemic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischaemic stroke with determination of infarct size by imaging (MRI)
- NIHSS 1-24
- CRP increase ≥ 5 mg/l within presumed 72 hours after stroke and/or CRP value > 10 mg/l
- written informed consent of the patient or his legal representative
Key exclusion criteria (9 listed)
- age < 18 years
- Severe dysphagia (danger of aspiration pneumonia)
- Clinical or laboratory evidence of a severe systemic infection
- Participation in other interventional studies
- Contraindications against apheresis therapy
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 | Apheresis group |
Primary outcome
Safety of CRP apheresis
Time frame: 24 hours after each apheresis
Incidence of expected and unexpected adverse effects
5 secondary outcomes
Stroke Severity
Time frame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Functional Outcome
Time frame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Dependency
Time frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Infarct size
Time frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Concentration of inflammatory biomarkers (CRP, IL-6, SAA)
Time frame: 0-7 days after infarction
Results and safety
The study was stopped early (reason given: sufficient recruitment of study patients based on the existing (and repeatedly adjusted) inclusion and exclusion criteria is not possible within a reasonable period of time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
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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.
Johannes Dorst, PD Dr. med. principal investigator
Universitätsklinik Ulm, Abteilung für Neurologie
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 Pentracor GmbH 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 May 2023. 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?
The study was stopped early (reason given: sufficient recruitment of study patients based on the existing (and repeatedly adjusted) inclusion and exclusion criteria is not possible within a reasonable period of time). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CRP apheresis (time frame: 24 hours after each apheresis). 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 18 May 2023.