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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010525

Enrollment

3000

Registered

2016-05-17

Start date

2014-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S06 S09

Interventions

Group 1: Treatment of patients with traumatic brain injury (TBI) will be documented (documentation forms: initial, acute, rehabilitation), and telefone interviews will be performed after 3 and 12 mont

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Germany

Contacts

Public ContactPeter Schwenkreis

Neurologische Klinik, BG-Universitätsklinikum Bergmannsheil

peter.schwenkreis@rub.de0234 302 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026