Using complement inhibition to reduce inflammation after subarachnoid hemorrhage

A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Subarachnoid Hemorrhage

This study is testing if a new treatment can help reduce inflammation and improve recovery in patients with bleeding in the brain caused by an aneurysm.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Haaglanden Medical Centre (Academic / other)
• Locations: 1 site (The Hague, South Holland)
• Trial ID: NCT06359782 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of C1-inhibitor Cinryze in patients diagnosed with aneurysmal subarachnoid hemorrhage (SAH). The study aims to determine if inhibiting the complement system can limit delayed cerebral ischemia and improve clinical outcomes by reducing neuroinflammation. Participants will receive either the C1-inhibitor or a placebo, and their progress will be monitored to assess the treatment's effectiveness. The trial focuses on patients with varying degrees of SAH severity as classified by the WFNS grading system.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of aneurysmal subarachnoid hemorrhage.

Not a fit: Patients with subarachnoid hemorrhage of non-aneurysmal origin or those with a very poor prognosis are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from aneurysmal subarachnoid hemorrhage.

How similar studies have performed: While the approach of complement inhibition is being explored, this specific application in SAH is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

The Hague, South Holland

• Haaglanden Medical Centre — The Hague, South Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Wouter Moojen, MD PHD — Haaglanden Medisch Centrum
• Study coordinator: Daan de Groot, MD

Conditions Subarachnoid Hemorrhage, Aneurysmal