Subarachnoid hemorrhage
Conditions
Interventions
The intervention group will receive intravenous eculizumab infusions.
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1) Confirmed aneurysmal SAH 2) Admission to the UMCU within 12 hours after ictus 3) Age 18 years and older
Exclusion criteria
Exclusion criteria: 1) Life expectancy 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is biological effectivity determined by the C5a concentration in CSF. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2) Occurrence of AEs and SAEs; 3) Blood plasma and CSF parameters of inflammation (e.g. CRP and cytokines); 4) Concentration of eculizumab in blood plasma and CSF; 5) Daily neurological condition measured by GCS during the first fourteen days of hospital stay; 6) Neurological condition measured by the NIHSS and WFNS score 14 days after ictus; 7) Cerebral infarction on brain MRI at hospital discharge; 8) Cognition and QoL ten weeks (+/- two weeks) after ictus; 9) The mRS thirteen weeks (+/- two weeks) after ictus. | — |
Contacts
Public ContactI. Koopman
Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Matthias van Geuns building
Outcome results
None listed