Using complement inhibition to reduce inflammation after subarachnoid hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: daan.de.groot@haaglandenmc.nl
• Phone: 088 979 7900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.