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Critical Hyperacute Assessment Research On Neurobiomarker Kinetics in Acute Brain Injury

NCT07782216 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 477

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

  • Brain Injuries, Traumatic
  • Brain Injuries, Acute
  • Hypoxia, Brain
  • Cardiac Arrest (CA)

Sponsors & Collaborators

  • Örebro University, Sweden

    collaborator OTHER

  • University of Pecs

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782216 on ClinicalTrials.gov