A multicentre prospective observational cohort study of incidence, acute care and recovery in the first year after moderate/severe traumatic brain injury in adults in the Netherlands.
Completed
- Conditions
- Head injuryTraumatic Braininjury1002211410029305
- Registration Number
- NL-OMON30993
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
Moderate and severe Traumatic Brain Injury (TBI). Moderate TBI is defined as a hospital admission Glasgow Coma Scale (GCS) 9- 12 (m/f). Severe TBI is defined as a hospital admission GCS <= 8 (m/f).
Admitted within 72 hours postinjury to one of the participating centres and aged 16 years or older.
Exclusion Criteria
Aged below 16 years
Mild TBI (GCS > 12)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary: GOSe</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary:<br /><br>a. General questions (eg. work, history)<br /><br>b.SF36<br /><br>c. Pain score list<br /><br>d. VVV (Fatigue questionnaire)<br /><br>e. RPQ (Rivermead)<br /><br>f. SVL (post-traumatic stress)<br /><br>g. BDI (depression)<br /><br>h. GOSE<br /><br>i PQOL (Quality of life)<br /><br>j. ESS (sleep scale)<br /><br>k. SCL-90 (Complaints list)<br /><br>l. VOW (Well being)<br /><br><br /><br><br /><br>Assessment of economic costs will be according to the *letsel last model*<br /><br>developed by Consument en Veiligheid</p><br>