Hemorrhagic stroke
Conditions
Interventions
- Cinryze (6000 IU): Cinryze is a C1 esterase inhibitor derived from human
plasma. The primary function of Cinryze is to regulate the activation of the
complement pathways. This regulation is done b
Sponsors
Haaglanden Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan - Age >= 18 years on admission - WFNS grade 1-5
Exclusion criteria
Exclusion criteria: - Subarachnoid hemorrhage deemed most likely to *peri mesencephalic* origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); - Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); - Participation in another clinical therapeutic study; - Patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission; - Patients with a known hereditary complement deficiency (including hereditary angioedema); - Patients with a history of sensibility to blood products or C1-inhibitor; - Patients with a history of thrombosis (when known at time of inclusion); - Pregnant woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: To assess efficacy of C1-INH in SAH patients, the difference of delayed cerebral ischemia (DCI) will be analysed between the treatment groups. The criteria consisted of either a new focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components). 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 (e.g. hydrocephalus or rebleeding). Safety: As this is a phase II study, we use a primary safety endpoint in addition to our primary efficacy endpoint. This safety endpoint is the patient's rate of complications during hospitalization. This percentage includes adverse events (including serious adverse events) that may be related to study medication. This includes, but is not limited to, venous thromboembolic events, hypersensitivity reactions, hyperglycaemia, sepsis, mortality. Events are listed by adverse event type, grade, and severity. Patients are assessed daily for these complications by a blinded doctor / nurse. Vital signs are closely monitored and potential side effects of the experimental treatment will be immediately noted in the ICU. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be measured during hospitalization and follow-up. During hospitalization: - Cerebral infarction on brain CT at 14 days - Mortality - Daily neurological condition measured by GCS during the first 14 days - Complement activity in serum and CSF - Inflammatory markers in serum and CSF - Coagulation cascade activation - ICU length of stay, ventilator days At discharge: - Hospital length of stay - Hospital disposition - Modified Rankin Scale (mRS Score) - Glasgow Outcome Score extended (GOSE) - Barthel Index (BI) - Montreal Cognitive Assessment (MoCA) - Quality of life (EQ-5D-5L) During follow-up at 6 months: - Modified Rankin Scale (mRS Score) - Glasgow Outcome Score extended (GOSE) - Barthel Index (BI) - Modified Telephone Interview for Cognitive Status (TICS-M) - Quality of life (EQ-5D-5L) | — |
Countries
Netherlands
Outcome results
None listed