Critical Hyperacute Assessment Research On Neurobiomarker Kinetics in Acute Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pecs
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Age under 18 years
Pre-existing neurological or psychiatric conditions
Hypothermia or hyperthermia at the time of enrollment
Pregnancy
Trial population
Adults aged 18 years or older presenting to emergency departments or prehospital emergency services in Hungary with acute brain injury (traumatic brain injury or cardiac arrest). Participants are enrolled consecutively at emergency departments, intensive care units, and by the Hungarian National Ambulance Service across multiple regions of Hungary.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
477 Participants
are grouped into 3 trial groupsGroup A: Prehospital TBI: Traumatic brain injury patients treated in prehospital setting
Group B: Prehospital Cardiac Arrest: Cardiac arrest patients treated in the prehospital setting
Group C: In-hospital TBI: Severe TBI patients enrolled at hospital admission
Trial outcomes
Primary outcomes
1
Prehospital Mortality
Death occurring prior to emergency department arrival, assessed in prehospital-enrolled participants.
Time frame
Day 1 (Up to 24 hours from enrollment)2
In-hospital Mortality
Death occurring during the hospital stay, assessed in all study arms.
Time frame
Up to 30 daysSecondary outcomes
1
Prehospital Neurological Status
Glasgow Coma Scale (GCS) score documented by the first-responding paramedic at the scene, prior to sedation or intubation. The GCS ranges from 3 (deep unconsciousness) to 15 (fully alert); higher scores indicate better neurological status.
Time frame
Baseline (At first prehospital contact)2
Abbreviated Injury Scale Score Assessment
The Abbreviated Injury Scale (AIS) categorizes injuries by body region on a scale from 1 (minor) to 6 (unsurvivable); higher scores indicate greater injury severity. Calculated based on clinical and imaging parameters at emergency department admission.
Time frame
[Time Frame: Day 1 (Up to 24 hours from enrollment)]3
Injury Severity Score Assessment
The Injury Severity Score (ISS) is an anatomical scoring system ranging from 0 to 75; higher scores indicate greater overall injury severity. The ISS is calculated from Abbreviated Injury Scale (AIS) scores, using clinical and imaging parameters assessed upon emergency department admission.
Time frame
[Time Frame: Day 1 (Up to 24 hours from enrollment)]4
Severity of Intracranial Pathology on Admission CT - Marshall Classification
Categories range from I (no visible intracranial pathology) to VI (diffuse injury with mass lesion); higher categories indicate greater severity of intracranial injury.
Time frame
[Time Frame: Day 1 (Up to 24 hours from enrollment)]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pecs
Lead sponsor
Örebro University, Sweden
Collaborator
Source ClinicalTrials.gov