[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659524":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":36,"overallOfficials":24,"centralContacts":41,"locations":47,"responsibleParty":66,"collaborators":24,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":24,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":24,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":49,"whyStopped":24,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Unidade Local de Saude Sao Jose","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Functional outcome measured by the Glasgow Outcome Scale - Extended (GOS-E)","Functional outcome assessed with the GOS-E (range 1-8; higher scores indicate better recovery), dichotomized as unfavorable (GOS-E 1-4) or favorable (GOS-E 5-8). Used as the dependent variable in multivariable prediction models including clinical, neuromonitoring and metabolomic variables.","1 year after hospital discharge",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"In-hospital mortality","All-cause death during the index hospitalization.","From ICU admission to hospital discharge (an average of 4 weeks)",{"measure":19,"description":20,"timeFrame":12},"All-cause mortality","Death from any cause",{"measure":22,"description":23,"timeFrame":12},"Discriminative performance of the prediction models","Area under the receiver operating characteristic curve (AUC) of multivariable models combining clinical, neuromonitoring and metabolomic variables for prediction of unfavorable functional outcome and mortality.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","Spontaneous subarachnoid hemorrhage (SAH) is associated with high morbidity and mortality, frequently affecting young adults. Established prognostic factors include age, clinical severity at admission (Hunt \\& Hess and WFNS scales) and imaging findings (modified Fisher scale), but existing prediction models have limited clinical implementation. Metabolomic profiling of blood and cerebrospinal fluid (CSF) may identify new prognostic biomarkers; Fourier-transform infrared (FT-IR) spectroscopy is a low-cost technique with potential for clinical translation.\n\nThis is a single-center, prospective, observational cohort study of consecutive adult patients with acute spontaneous SAH admitted to the Neurocritical Care and Trauma Unit (UCINCT) of ULS São José, Lisbon.\n\nData collected include demographics, comorbidities and risk factors; clinical scales (Glasgow Coma Scale every 8 hours, Hunt \\& Hess, WFNS); automated pupillometry; daily laboratory tests and arterial blood gases every 8 hours; neuron-specific enolase on days 1, 3 and 7; continuous physiological monitoring and, when clinically indicated, multimodal neuromonitoring (intracranial pressure and waveform, PRx, optimal cerebral perfusion pressure, brain tissue oxygen, brain temperature, video-EEG); transcranial Doppler, CT, MRI and angiography findings; treatments (aneurysm repair, decompressive surgery, vasospasm treatment) and complications.\n\nBlood and CSF samples are collected on days 1, 3 and 7, processed on site and stored at -80ºC at the NOVA Medical School biobank (CHAIN Biobank) for targeted and untargeted metabolomic analysis, performed in collaboration with Instituto Superior de Engenharia de Lisboa. Functional outcome is assessed one year after discharge using the Glasgow Outcome Scale - Extended (GOS-E).\n\nVariables associated with outcome in univariable analysis (p\\\u003C0.25) will be entered into multivariable logistic regression models. Model discrimination will be assessed by the area under the ROC curve.\n\nThe study was approved by the Ethics Committee of ULS São José \\[nº do parecer\\]. Written informed consent is obtained from patients or their legal representatives.","Consecutive adult patients with acute spontaneous subarachnoid hemorrhage admitted to the Neurocritical Care and Trauma Unit of Unidade Local de Saúde São José, a tertiary referral center in Lisbon, Portugal.",[31],{"label":32,"type":24,"description":33,"interventionNames":34},"Spontaneous subarachnoid hemorrhage","Consecutive adult patients (≥18 years) with acute spontaneous subarachnoid hemorrhage admitted to the Neurocritical Care and Trauma Unit of ULS São José.",[35],"Other: Blood and cerebrospinal fluid sampling",[37],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":24},"Blood and cerebrospinal fluid sampling","Collection of additional blood samples and cerebrospinal fluid samples (from drains already in place for clinical reasons) on days 1, 3 and 7 after symptom onset for metabolomic analysis and biobanking. No change to diagnostic or therapeutic management.",[32],[42],{"name":43,"role":44,"phone":45,"phoneExt":24,"email":46},"Bruno Maia, MD","CONTACT","+351 962192079","bruno.maia@ulssjose.min-saude.pt",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Lisbon","Lisbon District","1150-199","Portugal","PT",{"type":56,"coordinates":57},"Point",[58,59],-9.1498,38.72509,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":64,"phoneExt":24,"email":65},"Vera Tocha","+351 962190022","ucipnc.hsjose@ulssjose.min-saude.pt",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Bruno Maia","Head of Neurocritical Care Unit","100659524","metabolomics-in-subarachnoid-hemorrhage-100659524",false,"NCT07865182","Metabolomics in Subarachnoid Hemorrhage","New Predictive Models for Subarachnoid Hemorrhage - an Exploratory Study on Metabolomics","NeuroMetas","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of acute spontaneous (non-traumatic) subarachnoid hemorrhage\n* Admission to the Neurocritical Care and Trauma Unit of ULS São José\n\nExclusion Criteria:\n\n* Traumatic subarachnoid hemorrhage\n* Death before ICU admission\n* Refusal of informed consent by the patient or legal representative","ALL","18 Years",{"count":81,"type":82},100,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this observational study is to learn whether blood and cerebrospinal fluid markers, combined with clinical, imaging and brain monitoring data, can help predict the outcome of adults with spontaneous subarachnoid hemorrhage (bleeding around the brain not caused by trauma) admitted to the neurocritical care unit of Unidade Local de Saúde São José, in Lisbon, Portugal.\n\nThe main questions it aims to answer are:\n\nWhich substances (metabolites) in blood and cerebrospinal fluid are associated with death and with long-term disability after subarachnoid hemorrhage? Can a prediction model combining these markers with clinical and monitoring data predict the patient's recovery one year after hospital discharge?\n\nParticipants will receive standard care as decided by their treating physicians; the study will not change any diagnostic or treatment decision. In addition to routine care, participants will have small extra samples of blood and cerebrospinal fluid collected on days 1, 3 and 7 after the onset of the hemorrhage. Cerebrospinal fluid will only be collected from drains already in place for clinical reasons, and no additional invasive procedures will be performed. Samples will be stored in a biobank for metabolomic analysis. Participants will be assessed one year after hospital discharge to evaluate their recovery.",[87,88],"Subarachnoid Haemorrhage (SAH)","Delayed Cerebral Ischemia",[90,91,92,93,94,95,96,97,98],"metabolomics","biomarkers","prognosis","clinical prediction model","cerebrospinal fluid","Fourier Transform Infrared Spectroscopy","Multimodal Neuromonitoring","Neurocritical Care","Glasgow Outcome Scale-Extended","2026-10-02",{"date":101,"type":102},"2026-10-08","ACTUAL",{"date":104,"type":102},"2025-05-01",{"date":106,"type":82},"2027-10",{"name":5,"class":6},1]