I63
Conditions
Interventions
Group 1: 10 patients receive a maximum of 3 treatments at intervals of 24 ± 12 hours each (from the beginning of the preceeding treatment). No further treatments are carried out if the CRP concentrati
Sponsors
Pentracor GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Ischaemic stroke with determination of infarct size by imaging, NIHSS 1-24, CRP increase = 5 mg/l within presumably 72 hours after stroke and/or CRP value above 10 mg/l, Legal capacity, Written informed consent of the patient or a legal representative
Exclusion criteria
Exclusion criteria: Age < 18, Severe dysphagia (danger of aspiration pneumonia), Clinical or laboratory evidence of a severe systemic infection, Participation in another interventional study, 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 |
|---|---|
| Safety of CRP apheresis: Incidence of expected and unexpected adverse effects | — |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS score (National Institute of Health Stroke Scale) mRS (modified Rankin Scale) BI (Barthel Index) Infarct size (MRT volume change) The infarct size is determined by 2 additional MRIs 6 ± 3 days and 12 ± 2 weeks after the infarct, the scores at the same time. Biomarker of inflammation (CRP, interleukin-6 and serum amyloid A) are determined twice daily until discharge of the patient, but not more than 7 days after onset of symptoms. | — |
Countries
Germany
Contacts
Public ContactJohannes Dorst
Abteilung für Neurologie, Universität Ulm RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH
Outcome results
None listed