Subarachnoid Haemorrhage (SAH)NeuroMetasNCT07865182
Metabolomics in Subarachnoid Hemorrhage
An observational study of Subarachnoid Haemorrhage (SAH) and Delayed Cerebral Ischemia, run by Unidade Local de Saude Sao Jose at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Haemorrhage (SAH), Delayed Cerebral Ischemia
- What is being tested?
- Blood and cerebrospinal fluid sampling
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2025to Oct 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18 years or older
- Diagnosis of acute spontaneous (non-traumatic) subarachnoid hemorrhage
- Admission to the Neurocritical Care and Trauma Unit of ULS São José
Who cannot join
- Traumatic subarachnoid hemorrhage
- Death before ICU admission
- Refusal of informed consent by the patient or legal representative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saude Sao Jose
Lisbon, Lisbon District, 1150-199
Vera Tocha, +351 962190022, ucipnc.hsjose@ulssjose.min-saude.pt
About this study
Official title: New Predictive Models for Subarachnoid Hemorrhage - an Exploratory Study on Metabolomics
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:
Read more
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.
Read the detailed description
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.
- Being tested
- Blood and cerebrospinal fluid sampling
- Keywords
- metabolomics, biomarkers, prognosis, clinical prediction model, cerebrospinal fluid, Fourier Transform Infrared Spectroscopy, Multimodal Neuromonitoring, Neurocritical Care, Glasgow Outcome Scale-Extended
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and cerebrospinal fluid samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood and cerebrospinal fluid sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after hospital discharge
Secondary outcomes (3)
In-hospital mortality
All-cause death during the index hospitalization.
Measured: From ICU admission to hospital discharge (an average of 4 weeks)
All-cause mortality
Death from any cause
Measured: 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.
Measured: 1 year after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 May 2025
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Haemorrhage (SAH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saude Sao Jose
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Maia, Unidade Local de Saude Sao Jose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865182
- Sponsor's protocol ID
- 1481-2024
- Acronym
- NeuroMetas
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Predictive Models for Subarachnoid Hemorrhage - an Exploratory Study on Metabolomics
- ClinicalTrials.gov ID
- NCT07865182
- Acronym / sponsor ID
- NeuroMetas / 1481-2024
- Keywords
- metabolomics, biomarkers, prognosis, clinical prediction model, cerebrospinal fluid, Fourier Transform Infrared Spectroscopy, Multimodal Neuromonitoring, Neurocritical Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Unidade Local de Saude Sao JoseUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spontaneous subarachnoid hemorrhage | – | Other: Blood and cerebrospinal fluid samplingConsecutive adult patients (≥18 years) with acute spontaneous subarachnoid hemorrhage admitted to the Neurocritical Care and Trauma Unit of ULS São José. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Diagnosis of acute spontaneous (non-traumatic) subarachnoid hemorrhage
- Admission to the Neurocritical Care and Trauma Unit of ULS São José
Key exclusion criteria (3 listed)
- Traumatic subarachnoid hemorrhage
- Death before ICU admission
- Refusal of informed consent by the patient or legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and cerebrospinal fluid samplingCollection 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. | Other | Spontaneous subarachnoid hemorrhage |
Primary outcome
Functional outcome measured by the Glasgow Outcome Scale - Extended (GOS-E)
Time frame: 1 year after hospital discharge
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.
3 secondary outcomes
In-hospital mortality
Time frame: From ICU admission to hospital discharge (an average of 4 weeks)
All-cause mortality
Time frame: 1 year after hospital discharge
Discriminative performance of the prediction models
Time frame: 1 year after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Haemorrhage (SAH) and Delayed Cerebral Ischemia, run by Unidade Local de Saude Sao Jose at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Maia, MD (+351 962192079, bruno.maia@ulssjose.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome measured by the Glasgow Outcome Scale - Extended (GOS-E) (time frame: 1 year after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.