Aneurysmal subarachnoid hemorrhage (SAH) can lead to devastating outcomes for patients, like cognitive decline. This is caused by early brain injury (EBI) followed by delayed cerebral ischemia (DCI). Neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of EBI and DCI. Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH.
This trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response.
Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan;
Age ≥ 18 years on admission;
WFNS grade 1-5.
Subarachnoid hemorrhage deemed most likely of 'peri mesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (not originated from an aneurysm and patients have by definition a favourable clinical outcome)
Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (does not occur spontaneous)
Participation in another clinical therapeutic study;
Patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission
Parallel
C1 Esterase Inhibitor Injection [Cinryze]
DrugC1 Esterase Inhibitor Injection \[Cinryze\]
Placebo
DrugSodium Chloride /physiological saline (0.9%) in equal volume dosed intravenous
Number of participants with delayed cerebral ischemia (DCI)
Defined as either a new focal neurological impairment, or a decrease of at least 2 points on the Glasgow Coma Scale. This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies.
Number of participants with complications during hospitalization.
Complication rate during hospitalization
Number of participants with cerebral infarction on brain CT
Number of participants dying
Mortality rate
Neurological condition measured by Glasgow Coma Scale
Measured daily, minimum value of 3, maximal value of 15, higher scores mean a better outcome
Complement activity markers measured in serum and CSF
WIESLAB, C3b/C, C4b/C, C5b-9 ELISA assays, CH50/AC50
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