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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)

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older (all arms)

• Polytraumatized patients categorized as T1 triage by the first responder based on injury mechanism and/or sustained injuries, with intubation indicated by the first responder (Arm 1)

• Cardiac arrest treated in the prehospital setting (Arm 2)

• Severe traumatic brain injury enrolled at hospital admission (Arm 3)

Locations
Other Locations
Hungary
Hungarian National Ambulance Service
RECRUITING
Budapest
North Pest Central Hospital - Military Hospital, Emergency Centre
RECRUITING
Budapest
Petz Aladár University Teaching Hospital, Emergency Department
RECRUITING
Győr
University of Pécs Clinical Center, Department of Emergency Medicine
RECRUITING
Pécs
Contact Information
Primary
Endre Czeiter, MD, PhD
endre.czeiter@gmail.com
+36205576026
Backup
Ábel Papp, MD
pappabel0219@gmail.com
+36305539282
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 477
Treatments
Prehospital TBI: Traumatic brain injury patients treated in prehospital setting
Serial blood samples are collected from severely injured traumatic brain injury and/or polytrauma patients (ISS \>16 and/or GCS \<9) categorized as T1 triage in the prehospital setting. Sampling occurs at two prehospital time points (immediately after intravenous access is secured; immediately before transport initiation) and at four in-hospital time points (upon emergency department admission; 1, 6, and 24 hours after ED admission). No experimental intervention is administered; participants receive standard emergency care.
Prehospital Cardiac Arrest: Cardiac arrest patients treated in the prehospital setting
Serial blood samples are collected from cardiac arrest patients managed in the prehospital setting. Sampling occurs at three prehospital time points (after the first adrenaline dose or defibrillation; at 20 minutes of ongoing resuscitation; at return of spontaneous circulation or prior to declaration of death) and at four in-hospital time points (upon emergency department admission; 1, 6, and 24 hours after ED admission). No experimental intervention is administered; participants receive standard resuscitation care.
In-hospital TBI: Severe TBI patients enrolled at hospital admission
Serial blood samples are collected from severe TBI patients (ISS \>16 and/or GCS \<9) enrolled upon emergency department admission. Sampling occurs at four time points: upon ED admission and at 1, 6, and 24 hours after admission. No experimental intervention is administered; participants receive standard emergency and intensive care.
Sponsors
Leads: University of Pecs
Collaborators: Örebro University, Sweden

This content was sourced from clinicaltrials.gov