Actively Recruiting
Phase II Study of C1 Esterase Inhibitor Cinryze Compared to Placebo for Acute Treatment of Aneurysmal Subarachnoid Hemorrhage
Led by Haaglanden Medical Centre · Updated on 2024-12-27
128
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
H
Haaglanden Medical Centre
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Aneurysmal subarachnoid hemorrhage (SAH) is a serious condition that can cause severe outcomes such as cognitive decline. This decline results from early brain injury followed by delayed cerebral ischemia (DCI). Neuroinflammation driven by the complement system plays a key role in this process. Researchers are studying whether blocking the complement system with a drug called C1-inhibitor Cinryze can reduce inflammation and improve outcomes for patients with SAH. The trial compares the safety and effectiveness of C1-inhibitor Cinryze, an approved complement system inhibitor, with a placebo treatment. Patients will receive either the Cinryze injection or an intravenous dose of saline solution. The study focuses on the acute management of SAH during the hospital stay. Participants will be monitored for delayed cerebral ischemia between day 4 and day 14 after admission, and for complications during hospitalization up to one year later. Researchers will assess clinical outcomes and safety throughout this period to understand the potential benefits and risks of the treatment. The study includes adults aged 18 and older with confirmed aneurysmal SAH.
CONDITIONS
Official Title
Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan
- Age 18 years or older on admission
- World Federation of Neurosurgical Societies (WFNS) grade 1-5
You will not qualify if you...
- Subarachnoid hemorrhage likely of peri mesencephalic origin
- Subarachnoid hemorrhage likely of post-traumatic origin
- Participation in another clinical therapeutic study
- Definite poor prognosis on arrival or expected death within 24 hours of admission
- Known hereditary complement deficiency, including hereditary angioedema
- History of sensitivity to blood products or C1-inhibitor
- History of thrombosis known at time of inclusion
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Haaglanden Medical Centre
The Hague, South Holland, Netherlands, 2512HH
Actively Recruiting
Research Team
D
Daan de Groot, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here