A prospective study on epidemiology and outcome of patients with traumatic brain injury (TBI) in BG-hospitals

• Conditions: S06; S09; Intracranial injury; Other and unspecified injuries of head

• Registration Number: DRKS00010525
• Lead Sponsor: BG Universitätsklinikum Bergmannsheil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-17
• Study Completion: 2018-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3524

Inclusion Criteria

Epidemiological main project:
Patient with acute head injury, at least 18 years old, presentation at one of the participating hospitals within 24 hours afgter trauma and
1.At least one of the following symptoms:
-nausea/vomitting
-headache
-anterograde/retrograde amnesia
-impaired consciousness
-fracture of skull or face
-focal neurological sign

and/or

2. One of the following diagnosis:
- S02 Fracture of skull and facial bones
- S04 Injury of cranial nerves
- S06 Intracranial injury
- S07 Crushing injury of head
- S09 Other and unspecifed injuries of head

Subproject mild TBI:
Patient with mild TBI, defined by head injury and at least one of the following conditions:
-transient loss of consciousness <30min
-amnesia <24h
-transient qualitative or quantitative impairment of consciousness
-GCS 30 min after trauma between 13 and 15

Exclusion Criteria

main project:
age <18y

subproject:
-focal neurological sign
-intracranial bleeding or skull fracture as revealed by CCT
-relevant accompanying disorders
-history of neurological or psychiatric disorder
-contraindication for MRI
-insufficient knowledge of German language

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this study is to generate epidemiological data on medical care and outcome of patients with traumatic brain injury who are treated in BG hospitals in Germany. The current state of medical care in these hospitals is described by 3 standardized assessment forms. Besides, outcome of these patients is assessed by 2 standardized telephone interviews, which take place 3 and 12 months after trauma. Riisk factors for negative outcome after TBI shall be idenbtified.

Secondary Outcome Measures

Name	Time	Method
Abnormalities in neuropsychological examination 12 months after mild traumatic brain injury. Neuropsychological examination consists of cognitive tests (attention, verbal and nonverbal memory, cognitive speed, working memory, verbal fluency and validation of complaints) and self-reporting questionnaires on depression, anxiety and attention