Complement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Hemorrhage: safety and proof-of-concept

niversity Medical Center Utrecht0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年2月28日

适应症

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•1) Life expectancy < 10 days;
•2) Pregnant or breast-feeding women;
•3) Participation in another clinical therapeutic study;
•4) History of splenectomy or asplenia (potentially increased risk of meningococcal infection);
•5) Hematologic malignancy;
•6) Patients receiving chemotherapy;
•7) Patients who will undergo or underwent an organ transplantation;
•8) Patients with myasthenia gravis, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or tuberculosis;
•9) Patients who are or will be treated by plasmapheresis or hemodialysis;
•10) Patient with a creatinine clearance of <30 or serum creatinine levels of >169 µmol/l
•11) Patients with a known hereditary complement deficiency;
•12) Patients allergic to eculizumab, proteins derived from mouse products or other monoclonal antibodies;
•13) Patients allergic to (prophylactic) antibiotic treatment for Neisseria meningitidis (quinolones or ceftriaxone (therapeutic));
•14) If on admission, it is likely that the aneurysm can only be treated with extracranial-intracranial bypass surgery;
•15) If based on head imaging, it will be unlikely that CSF can be obtained 48-72 hours after ictus;
•16) Patients with an ongoing infection on admission which is not appropriately treated;
•17) Patients who were treated >4 times with antibiotics during the last year;
•18) Patients on immunosuppressive therapy.

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