EUCTR2017-004307-51-NL进行中（未招募）1 期
Complement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Hemorrhage: safety and proof-of-concept. - CLASH
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Confirmed aneurysmal SAH
- •2) Admission to either the UMCU or Erasmus MC within 11.5 hours after ictus
- •3) Age 18 years and older
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •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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