Inflammation inhibitors to reduce brain injury after a hemorrhagic stroke.

Phase 1

• Conditions: Aneurysmal subarachnoid hemorrhage; MedDRA version: 20.1Level: LLTClassification code 10042320Term: Subarachnoid hemorrhageSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004307-51-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified