Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage

Recruiting

• Conditions: Subarachnoid Hemorrhage, Aneurysmal; Subarachnoid Hemorrhage, Spontaneous

• Registration Number: NCT06218654
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Study Start: 2024-01-15
• Study First Posted: 2024-01-23
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-01-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarkers and patients outcome	t0 at 24 hours, t1 at 72 hours, t2 at 7 days	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).

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy