Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
The goal of this observational study is to learn about the role of biomarkers in spontaneous subarachnoid hemorrhage (sSAH) as predictors of severity of clinical outcome. The test of biomarkers is based on regular blood and urinary samples. Blood levels of highly specific cardiac troponin (cTNI), natriuretic peptides (NT-ProBNP), S100 beta protein, neuron-specific enolase (NSE), glial fibrillary acidic protein (GFAP), ubiquitin carboxy-terminal hydrolase (UCH-L1), soluble Tumor Necrosis Factor Receptor-2 (sST2), and soluble urokinase plasminogen activator receptor (suPAR), as well as urinary levels of epinephrine and norepinephrine are the biomarkers explored. All adult participants with spontaneous subarachnoid hemorrhage are involved in the study.
The main questions aim to answer are:
* which of these molecules can be prognostic for patients' outcome * which are the prognostic levels of these biomarkers to predict patients' outcome.
Participants will undergo blood and urinary samples during hospitalization at 24 hours, 72 hours and after 7 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with spontaneous subarachnoid hemorrhage, including those with perimesencephalic subarachnoid hemorrhage and aneurysmal subarachnoid hemorrhage.
Adult patients.
Confirmed presence of spontaneous subarachnoid hemorrhage through neuroimaging.
Obtained informed consent for specific study biomarkers
Disqualifiers
Age <18 years.
Post-traumatic subarachnoid hemorrhage.
Trial population
All adult patients (\>18 years) diagnosed with spontaneous subarachnoid hemorrhage admitted at the Fondazione Policlinico Universitario Agostino Gemelli will be enrolled in the study. Bleeding will be defined as hemorrhage measured on CT using a volumetry program conducted by the Department of Radiology. For all patients, angioCT and angiography (performed if necessary for diagnosis) data will be collected from the initial diagnosis. Radiological images obtained at the time of diagnosis will be collected and anonymized
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
biomarkers
Diagnostic testSerum tests for specific cardiac troponin (cTPI), neuron-specific enolase (NSE), natriuretic peptides (NT-ProBNP), S100 protein (S100B), Soluble Suppressor of Tumorigenesis-2 (sST2), and soluble urokinase plasminogen activator receptor (suPAR) tests will be performed, as well as urinary tests for epinephrine and norepinephrine. On these samples, conducted according to clinical practice, additional measurements will also be taken for glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase (UCH-L1) as specific study biomarkers on blood samples. All samples will be collected within 24 hours of admission to the Emergency Department (T0) and after 72 hours (T1). A sample at day 7 (T2) will be taken.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Biomarkers and patients outcome
Assessing biomarkers as prognostic factors through logistic regression analysis, adjusted for confounding factors (gender, age, imaging, neurological and systemic complications) that may influence clinical outcomes (mRS).
Time frame
t0 at 24 hours, t1 at 72 hours, t2 at 7 daysSponsors and contacts
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Source ClinicalTrials.gov