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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Selective CRP apheresis by use of the "PentraSorb"-CRP
Abteilung für Neurologie, Universität Ulm
Ulm, Bavaria, Germany
Safety of CRP apheresis
Incidence of expected and unexpected adverse effects
Time frame: 24 hours after each apheresis
Stroke Severity
National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome
Time frame: 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
Time frame: 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
Time frame: 6 ± 3 days after infarction and 12 ± 2 weeks after infarction
Infarct size
Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change
Time frame: 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).
Time frame: 0-7 days after infarction
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