Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage

NCT06218654 | Recruiting

• 1 other identifier: 6185
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage, Spontaneous; Subarachnoid Hemorrhage, Aneurysmal

Outcome Measures

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).

  t0 at 24 hours, t1 at 72 hours, t2 at 7 days

Interventions

biomarkers DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Environmental Biomarkers

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biomarkers; Biological Factors; Biological Phenomena; Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health

Study Officials

• Giuseppe Maria Della Pepa

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

• Anna Maria Auricchio

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  STUDY CHAIR

Central Study Contacts

Giuseppe Maria Della Pepa

CONTACT

+390630155701; giuseppemaria.dellapepa@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: January 15, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-01

Locations

IT (1)