NCT07782216 Critical Hyperacute Assessment Research On Neurobiomarker Kinetics in Acute Brain Injury
| NCT ID | NCT07782216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pecs |
| Condition | Brain Injuries, Traumatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 477 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 477 participants in total. It began in 2026-03-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria * 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) Exclusion Criteria (all arms) * Age under 18 years * Pre-existing neurological or psychiatric conditions * Hypothermia or hyperthermia at the time of enrollment * Pregnancy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07782216 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Injuries, Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07782216 currently recruiting?
Yes, NCT07782216 is actively recruiting participants. Contact the research team at endre.czeiter@gmail.com for enrollment information.
Where is the NCT07782216 trial being conducted?
This trial is being conducted at Pécs, Hungary, Győr, Hungary, Budapest, Hungary, Budapest, Hungary.
Who is sponsoring the NCT07782216 clinical trial?
NCT07782216 is sponsored by University of Pecs. The trial plans to enroll 477 participants.