A Phase II Study of C1 Esterase Inhibitor Cinryze for Treatment of Aneurysmal Subarachnoid Hemorrhage to Reduce Brain Inflammation and Improve Outcomes

What this Trial Is About

Aneurysmal subarachnoid hemorrhage SAH can cause serious complications such as cognitive decline due to early brain injury followed by delayed cerebral ischemia. Neuroinflammation triggered by the complement system is believed to play a key role in this process. Researchers are studying whether blocking the complement system with the drug C1-inhibitor Cinryze can reduce delayed cerebral ischemia and improve outcomes in patients with SAH. This phase II trial compares the safety and effects of C1-esterase inhibitor Cinryze to a placebo in patients diagnosed with aneurysmal SAH. Participants are randomly assigned to receive either the study drug or placebo through intravenous administration. The trial is designed with quadruple masking to ensure unbiased results. Participants will be monitored for delayed cerebral ischemia between days 4 and 14 after admission, with ongoing observation for complications during hospitalization and up to one year after. Assessments include brain CT scans, neurological evaluations, and measurements of complement and inflammatory markers in blood and cerebrospinal fluid before and after treatment. Clinical outcomes are evaluated at six months, and hospital stay details such as ICU and ventilator days are recorded to assess safety and efficacy over time.

Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH)