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Complement Inhibition: Attacking the Overshooting Inflammation @fter Subarachnoid Hemorrhage - A phase II trial on the safety and efficacy of C1 esterase inhibitor for the acute management of subarachnoid hemorrhage

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520540-15-00
Enrollment
128
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aneurysmal subarachnoid hemorrhage

Brief summary

Number of participants with delayed cerebral ischemia (DCI). Defined as either a new focal neurological impariment, 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 bij means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies, Number of participants with complications during hospitalization

Detailed description

Cerebral infarction on brain CT at 14 days, Mortality, Daily neurological condition measured bij GCS during the first 14 days, Complement activity in serum and CSF, Coagulation cascade activation, ICU length of stay, Ventilator days

Interventions

DRUGSodium Chloride 0.9% w/v Intravenous Infusion BP Solution for Infusion.

Sponsors

Haaglanden Medisch Centrum Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of participants with delayed cerebral ischemia (DCI). Defined as either a new focal neurological impariment, 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 bij means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies, Number of participants with complications during hospitalization

Secondary

MeasureTime frame
Cerebral infarction on brain CT at 14 days, Mortality, Daily neurological condition measured bij GCS during the first 14 days, Complement activity in serum and CSF, Coagulation cascade activation, ICU length of stay, Ventilator days

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026