Haaglanden Medical Centre
The Hague, South Holland, 2512HH, Netherlands
Location status: Recruiting
NCT Number: NCT06359782
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
The Hague, South Holland, 2512HH, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
C1 Esterase Inhibitor Injection [Cinryze]
Other names: Cinryze
Sodium Chloride /physiological saline (0.9%) in equal volume dosed intravenous
Time frame: To be determined between day 4 and day 14 of admission
Defined as either a new focal neurological impairment, or a decrease of at least 2 points on the Glasgow Coma Scale. This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies.
Time frame: Up to 1 year after admission
Complication rate during hospitalization
Time frame: at 14 days after admission
Time frame: Up to 1 year after admission
Mortality rate
Time frame: During the first 14 days
Measured daily, minimum value of 3, maximal value of 15, higher scores mean a better outcome
Time frame: Before IV administration of C1-INH or placebo, and after 48 hours and 96 hours after IV administration
WIESLAB, C3b/C, C4b/C, C5b-9 ELISA assays, CH50/AC50
Time frame: Before IV administration of C1-INH or placebo, and after 48 hours and 96 hours after IV administration
TNF-alpha, intraleukins
Time frame: Up to 1 year
Hospital length of stay
Time frame: Up to 1 year
ICU length of stay
Time frame: Up to 1 year
Ventilator days
Time frame: At 6 months
Modified Ranking Scale, minimum value 0, maximum value 6, higher score means worse outcome
Time frame: At 6 months
Glasgow Outcome Scale Extended, minimum value 1, maximum value 8, higher score means better outcome
Time frame: At 6 months
Barthel Index, minimum value 0, maximum value 100, higher score means better outcome
Time frame: At 6 months
Montreal Cognitive assessment, minimum value 0, maximum value 30, higher score means better outcome
Time frame: At 6 months
Quality of Life (EQ-5D-5l), minimum value -0.51, maximum value 1, higher score means better outcome
Contact information is provided by the study sponsor or research team.
Haaglanden Medical Centre
Other
A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Subarachnoid Hemorrhage
Acronym: CIAO@SAH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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