Metabolomics in Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnidade Local de Saude Sao Jose
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Traumatic subarachnoid hemorrhage
Death before ICU admission
Refusal of informed consent by the patient or legal representative
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood and cerebrospinal fluid sampling
Other interventionCollection 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Spontaneous subarachnoid hemorrhage1 intervention
Trial outcomes
Primary outcomes
1
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 dischargeSecondary outcomes
1
In-hospital mortality
All-cause death during the index hospitalization.
Time frame
From ICU admission to hospital discharge (an average of 4 weeks)2
All-cause mortality
Death from any cause
Time frame
1 year after hospital discharge3
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 dischargeSponsors and contacts
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Source ClinicalTrials.gov