RecruitingNCT07782216

Critical Hyperacute Assessment Research On Neurobiomarker Kinetics in Acute Brain Injury

Investigating the Significance of Protein Biomarkers During the Hyperacute Phase of Traumatic Brain Injury and Other CNS Conditions With Hypoxia/Hypoperfusion in Emergency and Prehospital Settings (CHARON)


Sponsor

University of Pecs

Enrollment

477 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Traumatic brain injury (TBI) and other conditions that reduce blood flow to the brain - such as cardiac arrest (CA) - are life-threatening medical emergencies. When brain cells are damaged, they release specific proteins into the bloodstream. These proteins, called neurobiomarkers, can be measured in blood samples and may help doctors assess the severity of brain injury, guide treatment, and predict patient outcomes. A major gap in current knowledge is how these neurobiomarkers behave during the very first minutes and hours after injury - the so-called "hyperacute" phase - especially when patients are still being treated by paramedics or have just arrived at the emergency department (ED). It is not yet clear whether biomarker levels rise immediately at the moment of injury or gradually over time, and how quickly they can be reliably detected. The CHARON study investigates the time-dependent kinetics of key neurobiomarkers - including S100B, glial fibrillary acidic protein (GFAP), neuron-specific enolase (NSE), ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), neurofilament light chain (NFL), and Tau proteins- during the hyperacute phase of acute brain injury. In addition to these proteins, microRNAs, polar metabolites, and lipid metabolites are also examined as potential biomarkers. The study enrolls three groups of participants: * Patients with severe traumatic brain injury and/or polytrauma treated in the prehospital setting and admitted to the ED with T1 (highest priority) triage classification. * Patients with CA treated (resuscitated) in the prehospital setting. * Patients with severe traumatic brain injury enrolled at hospital (ED) admission. Serial blood samples are collected at multiple time points, beginning during prehospital care and continuing through the first 24 hours of hospital admission. No experimental treatments are given - all participants receive standard medical care. By analyzing biomarker concentration and kinetics across all three groups and correlating findings with neurological outcome at 30 days, the investigators aim to identify the most clinically effective neurobiomarkers for early diagnosis and prognosis of acute brain injury. The study is a prospective multi-center investigation conducted at emergency departments, intensive care units, and ambulance services across Hungary.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with brain injuries, acute, brain injuries, traumatic, and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

University of Pécs Clinical Center, Department of Emergency Medicine

Pécs, Branya, Hungary

Petz Aladár University Teaching Hospital, Emergency Department

Győr, Győr-Moson-Sopron, Hungary

Hungarian National Ambulance Service

Budapest, Pest County, Hungary

North Pest Central Hospital - Military Hospital, Emergency Centre

Budapest, Pest County, Hungary

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NCT07782216


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