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Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH)
Sponsor: Haaglanden Medical Centre
Summary
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.
Official title: A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Subarachnoid Hemorrhage
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2024-11-04
Completion Date
2027-03
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
C1 Esterase Inhibitor Injection [Cinryze]
C1 Esterase Inhibitor Injection \[Cinryze\]
Placebo
Sodium Chloride /physiological saline (0.9%) in equal volume dosed intravenous
Locations (1)
Haaglanden Medical Centre
The Hague, South Holland, Netherlands