NCT06359782 Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH)
| NCT ID | NCT06359782 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Haaglanden Medical Centre |
| Condition | Subarachnoid Hemorrhage, Aneurysmal |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 128 participants in total. It began in 2024-11-04 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Wouter Moojen, MD PHD
PRINCIPAL INVESTIGATOR
Haaglanden Medisch Centrum
Frequently Asked Questions
Who can join the NCT06359782 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Subarachnoid Hemorrhage, Aneurysmal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06359782 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06359782 currently recruiting?
Yes, NCT06359782 is actively recruiting participants. Contact the research team at daan.de.groot@haaglandenmc.nl for enrollment information.
Where is the NCT06359782 trial being conducted?
This trial is being conducted at The Hague, Netherlands.
Who is sponsoring the NCT06359782 clinical trial?
NCT06359782 is sponsored by Haaglanden Medical Centre. The principal investigator is Wouter Moojen, MD PHD at Haaglanden Medisch Centrum. The trial plans to enroll 128 participants.