RecruitingNCT06218654

Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage

Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage and Systemic Response to Endogenous Stress. Urinary and Serum Factors and Clinical Developments. Pilot Study Toward the Predictivity of Clinical Failure and Variation on Outcome in the Neurosurgical Patient (HISAHES)


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

90 participants

Start Date

Jan 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria2

  • Age \<18 years.
  • Post-traumatic subarachnoid hemorrhage.

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Interventions

DIAGNOSTIC_TESTbiomarkers

Serum 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.


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

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NCT06218654


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