An observational study in Subarachnoid Haemorrhage (SAH) and Delayed Cerebral Ischemia, sponsored by Unidade Local de Saude Sao Jose. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Unidade Local de Saude Sao Jose · 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.
The main questions it aims to answer are:
Which 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?
Participants 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.
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.
This 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.
Data 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.
Blood 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).
Variables associated with outcome in univariable analysis (p\<0.25) will be entered into multivariable logistic regression models. Model discrimination will be assessed by the area under the ROC curve.
The 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.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's planned enrollment of 100 is below the median of 117 across 226 observational studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →This is the only study on the registry with Unidade Local de Saude Sao Jose as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Consecutive adult patients (≥18 years) with acute spontaneous subarachnoid hemorrhage admitted to the Neurocritical Care and Trauma Unit of ULS São José.
Other: 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.
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.
Time frame: 1 year after hospital discharge
In-hospital mortality
All-cause death during the index hospitalization.
Time frame: From ICU admission to hospital discharge (an average of 4 weeks)
All-cause mortality
Death from any cause
Time frame: 1 year after hospital discharge
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.
Time frame: 1 year after hospital discharge
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Sharing of de-identified individual participant data may be considered upon reasonable request to the principal investigator, subject to approval by the Ethics Committee and the Data Protection Officer of ULS São José, and in compliance with the EU General Data Protection Regulation.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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