Inflammation inhibitors to reduce brain injury after a hemorrhagic stroke.

• Conditions: Subarachnoid hemorrhage; Early brain injury; Delayed cerebral ischemia. <br /><br />Subarachnoïdale bloeding; Vroege hersenschade; Secundaire ischemie.

• Registration Number: NL-OMON22901
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1) Confirmed aneurysmal SAH

2) Admission to the UMCU within 12 hours after ictus

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is biological effectivity determined by the C5a concentration in CSF.

Secondary Outcome Measures

Name	Time	Method
2) Occurrence of AEs and SAEs; <br /><br>3) Blood plasma and CSF parameters of inflammation (e.g. CRP and cytokines);<br /><br>4) Concentration of eculizumab in blood plasma and CSF; <br /><br>5) Daily neurological condition measured by GCS during the first fourteen days of hospital stay; <br /><br>6) Neurological condition measured by the NIHSS and WFNS score 14 days after ictus;<br /><br>7) Cerebral infarction on brain MRI at hospital discharge; <br /><br>8) Cognition and QoL ten weeks (+/- two weeks) after ictus; <br /><br>9) The mRS thirteen weeks (+/- two weeks) after ictus.