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

NCT06359782 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Haaglanden Medical Centre

Phase

Phase 2

Started

2024-11-04

Last updated

2024-12-27

Condition(s) studied

Subarachnoid Hemorrhage, Aneurysmal

Investigational drug(s) / intervention(s)

C1 Esterase Inhibitor Injection [Cinryze]Placebo

C1 Esterase Inhibitor Injection [Cinryze]: C1 Esterase Inhibitor Injection \[Cinryze\]

Placebo: Sodium Chloride /physiological saline (0.9%) in equal volume dosed intravenous

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan; * Age ≥ 18 years on admission; * WFNS grade 1-5. Exclusion Criteria: * 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 * 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

Primary outcome measure(s)

Number of participants with delayed cerebral ischemia (DCI) — To be determined between day 4 and day 14 of admission
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. — Up to 1 year after admission
Complication rate during hospitalization

Trial sites (1)

Facility	City	Region	Status
Haaglanden Medical Centre	The Hague	South Holland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06359782 on ClinicalTrials.gov ↗ ← All trials in the Netherlands