CASTRO1 - Study on CRP Apheresis After Ischemic Stroke (CASTRO1)
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|ClinicalTrials.gov Identifier: NCT04417231|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : March 24, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Ischemic||Device: CRP apheresis||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP-apheresis) in Ischemic Stroke|
|Actual Study Start Date :||January 28, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||March 2023|
Experimental: Apheresis group
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.
Device: CRP apheresis
Selective CRP apheresis by use of the "PentraSorb"-CRP
No Intervention: Control group
10 patients of the control group receive the same examinations as arm 1 (verum group) but no apheresis treatments after ischemic stroke.
- Safety of CRP apheresis [ Time Frame: 24 hours after each apheresis ]Incidence of expected and unexpected adverse effects
- Stroke Severity [ Time Frame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction ]National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome
- Functional Outcome [ Time Frame: before first apheresis and 6 ± 3 days after infarction and 12 ± 2 weeks after infarction ]Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome
- Dependency [ Time Frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction ]Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome
- Infarct size [ Time Frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction ]Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
- Concentration of inflammatory biomarkers (CRP, IL-6, SAA) [ Time Frame: 0-7 days after infarction ]CRP, Interleukin-6, and serum amyloid A are determined twice daily until discharge of the patient (for a maximum of 7 days).
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): NCT04417231
|Contact: Burghard Thiesen, Dr.||email@example.com|
|Abteilung für Neurologie, Universität Ulm||Recruiting|
|Ulm, Bayern, Germany|
|Contact: Johannes Dorst, MD|
|Principal Investigator:||Johannes Dorst, PD Dr. med.||Universitätsklinik Ulm, Abteilung für Neurologie|