Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

— HISAHES  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218654
• Other study ID #: 6185
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: January 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Giuseppe Maria Della Pepa
• Phone: +390630155701
• Email: giuseppemaria.dellapepa[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Spontaneous subarachnoid hemorrhage (sSAH) is one of the most severe neurological conditions. The hemodynamic instability due to endogenous catecholamine response and inflammatory patterns influences the risk of an unfavorable outcome and the development of clinical implications such as neurological and non-neurological issues. Serum 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, can be measured as biomarkers in sSAH to explore the systemic response to the stress of bleeding. However, not all sSAH cases equally develop this endogenous cascade responsible for neurological and systemic events. There is no clear validation of threshold levels of endogenous factors applicable in clinical practice to define hemodynamic instability that has only a neurological or multi-organ impact post-SAH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal
• Subarachnoid Hemorrhage, Spontaneous

Intervention

Diagnostic Test:
• biomarkers
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

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	t0 at 24 hours, t1 at 72 hours, t2 at 7 days