Aneurysmal subarachnoid hemorrhage MedDRA version: 20.1 Level: LLT Classification code 10042320 Term: Subarachnoid hemorrhage System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Soliris
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: ECULIZUMAB
CAS Number: 219685-50-4
Current Sponsor code: h5G1.1-mAb
Other descriptive name: Soliris
Concentration uni
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| Secondary Objective: The secondary outcome measures are the occurrence of adverse events (AEs) and serious adverse events (SAEs), plasma and cerebrospinal fluid (CSF) parameters of inflammation, quality of life (QoL), functional, and cognitive outcomes, and the presence and volume of cerebral infarction;Primary end point(s): The primary outcome measure is biological effectivity determined by the concentration of C5a in CSF. ;Timepoint(s) of evaluation of this end point: -48-72 hours after ictus ;Main Objective: This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Occurrence of AEs and SAEs up until one month after ictus 2) Blood plasma and CSF parameters of inflammation (e.g. CRP and cytokines); 3) Concentration of eculizumab in blood plasma and CSF; 4) Daily neurological condition during the first fourteen days of the hospital stay measured by Glasgow Coma Scale (GCS); 5) Neurological condition measured by the National Institutes of Health Stroke Scale (NIHSS) and World Federation of Neurosurgical Societies (WFNS)score fourteen days after ictus; 6) Cerebral infarction on brain Magnetic Resonance Imaging (MRI) at hospital discharge; 7) Cognition and QoL ten weeks (+/- two weeks) after ictus; 8) The modified Rankin Scale (mRS) thirteen weeks (+/- two weeks) after ictus. ;Timepoint(s) of evaluation of this end point: 1) Four weeks; 2 & 3) Blood plasma during hospital stay at multiple timepoints (on admission and on day 2, 4, 6, 9, 12 and 14). CSF 48-72 hours after ictus; 4) Daily during the first fourteen days of the hospital stay; 5) On day 14; 6) At discharge; 7) Ten weeks after ictus (+/- two week); 8) Thirteen weeks after ictus (+/- two weeks). | — |
Countries
Netherlands
Contacts
Public ContactNeurology department
University Medical Center Utrecht
Outcome results
None listed