Actively Recruiting
Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH)
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) 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.
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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