protocolSection identificationModule nctId: NCT06359782, orgStudyIdInfo id: NL76082.058.20, briefTitle: Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH), acronym: CIAO@SAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Haaglanden Medical Centre, class: OTHER, collaborators name: Leiden University Medical Center, collaborators name: Takeda, descriptionModule briefSummary: 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., conditionsModule conditions: Subarachnoid Hemorrhage, Aneurysmal, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, multicenter, randomized, double-blind, placebo-controlled, phase II trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: C1 Esterase Inhibitor Injection [Cinryze], interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with delayed cerebral ischemia (DCI), primaryOutcomes measure: Number of participants with complications during hospitalization., secondaryOutcomes measure: Number of participants with cerebral infarction on brain CT, secondaryOutcomes measure: Number of participants dying, secondaryOutcomes measure: Neurological condition measured by Glasgow Coma Scale, secondaryOutcomes measure: Complement activity markers measured in serum and CSF, secondaryOutcomes measure: Inflammatory markers measured in serum and CSF, secondaryOutcomes measure: Number of days in the hospital, secondaryOutcomes measure: Number of ICU days, secondaryOutcomes measure: Number of ventilator days, secondaryOutcomes measure: Clinical outcome, secondaryOutcomes measure: Clinical outcome, secondaryOutcomes measure: Clinical outcome, secondaryOutcomes measure: Clinical outcome, secondaryOutcomes measure: Clinical outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False