S06
Conditions
Interventions
Group 1: In patients presenting to the emergency department with a mild traumatic brain injury (mTBI) who meet the inclusion criteria, blood samples will be collected following written informed consen
Sponsors
Zentrale Notaufnahme Charité Universitätsmedizin Berlin Campus Virchow
Eligibility
Sex/Gender
All
Age
18 Years to 67 Years
Inclusion criteria
Inclusion criteria: Adult patients (=18 years) presenting to the ED within 24 hours of head injury, with a Glasgow Coma Scale (GCS) score of 13–15 after 30 minutes post-injury or upon presentation for healthcare, and at least one of the following criteria: •Alteration of mental status immediately after the injury (confusion, disorientation, difficulty concentrating) •Loss of consciousness for 30 minutes or less •Traumatic amnesia (of any type) lasting = 24 hours •Acute neurological abnormalities immediately after the injury (visual disturbances, focal deficits, reported seizure) •New or progressive clinical symptoms following the trauma (nausea, headache, vomiting, dizziness, visual disturbances, sensitivity to light and/or noise)
Exclusion criteria
Exclusion criteria: Age > 67 years Penetrating head injuries Polytrauma Unable to provide informed consent Other significant concurrent injuries Inability to provide informed consent personally Language barrier (patients who speak neither German nor English) Significant psychiatric or neurological pre-existing conditions (such as schizophrenia, psychosis, anxiety disorder, depression, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, epilepsy, or stroke)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Development of post-concussion syndrome (PCS) (Definition: Presence of PCS as per ICD-10 criteria, characterized by symptoms such as headache, dizziness, cognitive impairment, and emotional disturbances persisting for more than 3 months post-injury. Assessment: Two follow-up assessments (at 2 weeks and 3 months) through structured interviews or validated symptom questionnaires (Rivermead Post-Concussion Symptoms Questionnaire) to evaluate PCS development and severity.) • Duration of Work Absence (Definition: Number of days from injury until the patient resumes full work or daily activities. Including number of days until the patient resumes at least 50% of their previous working hours. Assessment: Collected during follow-up calls or visits, with patients reporting the time taken to resume normal activities. For non-employed patients, time to return to regular daily activities will be recorded.) | — |
Secondary
| Measure | Time frame |
|---|---|
| • The need for acute intervention/hospital admission • ED and hospital length of stay • Readmission to the emergency department (ED) or number of visits in EDs or GP after discharge • Identification of risk factors for Post-Concussion Syndrome (PCS) • Exploration of sex related differences in biomarker levels and long-term outcomes, including PCS, hospital and ED length of stay, and recovery time. • Comparison of standard care with biomarker-guided decision-making for CT scans (retrospectively) i.e. possible reduction in percentage of CT scans • Assessment of Turnaround Time for Biomarker Results | — |
Countries
Germany
Contacts
Public ContactTobias Lindner
Zentrale Notaufnahme Charité Campus Virschow Klinikum
Outcome results
None listed