Actively Recruiting
A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Subarachnoid Hemorrhage
Led by Haaglanden Medical Centre · Updated on 2024-12-27
128
Participants Needed
1
Research Sites
N/A
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 cause serious complications such as cognitive decline due to early brain injury followed by delayed cerebral ischemia. Neuroinflammation triggered by the complement system is believed to play a key role in this process. Researchers are studying whether blocking the complement system with the drug C1-inhibitor Cinryze can reduce delayed cerebral ischemia and improve outcomes in patients with SAH. This phase II trial compares the safety and effects of C1-esterase inhibitor Cinryze to a placebo in patients diagnosed with aneurysmal SAH. Participants are randomly assigned to receive either the study drug or placebo through intravenous administration. The trial is designed with quadruple masking to ensure unbiased results. Participants will be monitored for delayed cerebral ischemia between days 4 and 14 after admission, with ongoing observation for complications during hospitalization and up to one year after. Assessments include brain CT scans, neurological evaluations, and measurements of complement and inflammatory markers in blood and cerebrospinal fluid before and after treatment. Clinical outcomes are evaluated at six months, and hospital stay details such as ICU and ventilator days are recorded to assess safety and efficacy over time.
CONDITIONS
Brief 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
- 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 infaust prognosis 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 when known at time of inclusion
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive either the C1-esterase inhibitor (Cinryze) or a placebo by intravenous injection for acute management of subarachnoid hemorrhage.
Assessments before treatment and at 48 hours and 96 hours after administration
Duration - Up to 1 year
Participants are monitored for delayed cerebral ischemia, complications, and clinical outcomes up to 1 year after admission.
Clinical assessments at 14 days, 6 months, and throughout hospitalization
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
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