Subarachnoid Hemorrhage, SpontaneousHISAHESNCT06218654
Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, Spontaneous and Subarachnoid Hemorrhage, Aneurysmal, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- biomarkers
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Age <18 years.
- Post-traumatic subarachnoid hemorrhage.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Giuseppe Maria Della Pepa, +390630155701, giuseppemaria.dellapepa@policlinicogemelli.it
Giuseppe Maria Della Pepa
About this study
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)
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:
Read more
- 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.
Read the 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.
- Being tested
- biomarkers
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarkersDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: t0 at 24 hours, t1 at 72 hours, t2 at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start15 Jan 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, SpontaneousStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Maria Della Pepa, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSAnna Maria Auricchio, Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218654
- Sponsor's protocol ID
- 6185
- Acronym
- HISAHES
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06218654
- Acronym / sponsor ID
- HISAHES / 6185
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age <18 years.
- Post-traumatic subarachnoid hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biomarkersSerum 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. | Diagnostic test | – |
Primary outcome
Biomarkers and patients outcome
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Maria Della Pepa principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Anna Maria Auricchio study chair
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Spontaneous and Subarachnoid Hemorrhage, Aneurysmal, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Maria Della Pepa (+390630155701, giuseppemaria.dellapepa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers and patients outcome (time frame: t0 at 24 hours, t1 at 72 hours, t2 at 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.