Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06218654
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-01-12
Brief Title:
Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HISAHES
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None