Stroke, Ischemic
Conditions
Brief 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. 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.
Interventions
DEVICECRP apheresis
Selective CRP apheresis by use of the PentraSorb-CRP
Sponsors
Pentracor GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Intracranial hemorrhage * Epileptic seizure in the context of the acute event * Pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of CRP apheresis | 24 hours after each apheresis | Incidence of expected and unexpected adverse effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Severity | 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 | 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 | 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 | 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) | 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). |
Countries
Germany
Outcome results
None listed