S06.0 S02.0 S06.8 S06.9
Conditions
Interventions
Group 1: In the control group, a structured medical history and physical examination will be performed using a software tool developed specifically for our study documentation and the structuring of m
Sponsors
Universität Duisburg-Essen
Eligibility
Sex/Gender
All
Age
3 Months to 17 Years
Inclusion criteria
Inclusion criteria: - Head injury caused by direct or indirect mechanical force - At least one neurological symptom related to the head injury was/is present and/or there is a simple skull vault fracture - GCS = 14 upon arrival in the emergency department - The structured medical history and examination reveal no increased risk or indication of a clinically relevant intracranial complication - The trauma occurred = 48 hours ago - The legal guardians have sufficient German language skills for providing the medical history, understanding information about the mild traumatic brain injury, and using the app - A suitable device is available for the legal guardians to use the app
Exclusion criteria
Exclusion criteria: - Unconsciousness >30 minutes - Head injury in the context of high-impact trauma - Head injury due to an explosion (so-called blast injury) - Penetrating injury - Open traumatic brain injury (TBI) - Known bleeding tendency/indication of a coagulation disorder - Known severe internal, oncological, or hematological underlying condition associated with an increased risk of complications or bleeding - Known (developmental) neurological underlying condition - Difficulty in reliably assessing the neurological status of the patient - Presence of a shunt/valve in cases of known elevated intracranial pressure/hydrocephalus - Use of medications that impair blood coagulation - Indications of intoxication (alcohol/medication/drugs/other substances) - Indications of injury with suicidal intent - Indications of child abuse - Indication for hospital admission due to associated injuries or social/structural reasons - Occupational accident insurance (Berufsgenossenschaft) case/private health insurance (PKV) case, as these are excluded by the sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoints: - proportion of hospitalizations - proportion of cases with unplanned re-presentation within 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| - secondary hospitalization - amount of re-presentations (plannd and unplanned) - primary unidentified clinical relevant intracranial damage - admission to intensive care unit - neurosurgical intervention - death - cost/cost-effectiveness -acceptance of procedure and challanges for the implementation | — |
Countries
Germany
Contacts
Public ContactNora Bruns
Universität Duisburg-Essen
Outcome results
None listed