A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury (TBI-PRO)
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|ClinicalTrials.gov Identifier: NCT03810222|
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : February 24, 2021
Traumatic brain injury (TBI) is the leading cause of death, disability and cognitive impairment in young people worldwide. The majority of the traumatic deaths in developed countries results directly from lesions in the central nervous system. Furthermore, due to the persistence of disabling effects of TBI for many years, personal and public costs of supporting survivors have to be taken in consideration.
Many patients rescued by ICU treatment may have been severely disabled or vegetative because of trauma. These data suggest that, despite improvement in medical and surgical treatments, other factors related to trauma itself and to patient's condition could have an impact on the final outcome.
Aim of the TBI-PRO project is to collect high quality clinical and epidemiological data and to describe the outcome of moderate-to-severe TBI in a local contest (Bergamo area, Italy).
|Condition or disease||Intervention/treatment|
|Brain Injuries, Traumatic Brain Injury Traumatic Moderate Brain Injury Traumatic Severe||Other: N/A (Observational Study)|
|Study Type :||Observational|
|Actual Enrollment :||225 participants|
|Official Title:||A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury in Bergamo Area (Italy)|
|Actual Study Start Date :||January 18, 2017|
|Actual Primary Completion Date :||January 31, 2020|
|Actual Study Completion Date :||January 31, 2020|
- Other: N/A (Observational Study)
This is an observational study and does not include interventions. Exposure is TBI.
- Glasgow Outcome Scale - Extended (GOSE) [ Time Frame: 12 Months Post-Injury ]The global functional outcome at 12 months is assessed using the Glasgow Outcome Scale-Extended (GOS-E), obtained through structured interview. The GOS-E is a well-validated, widely employed measure of disability based on information on independence, employability, and social/community participation. The baseline function prior to injury is assessed to ensure that the deficit can be attributed to the event. GOS-E is dichotomized into favorable (a score of 5 to 8, Moderate Disability is defined by a score of 5-6) and unfavorable (a score of 1 to 4, Dead is defined by a score of 1).
- 6-Month Outcome [ Time Frame: 6 Months Post-Injury ]The functional outcome at 6 months is assessed using the GOS-E, neuroradiological findings (MRI Brain scan or CT) obtained within a 6 month-period post-injury are also considered.
- Neuropsychological evaluation [ Time Frame: 12 Months Post-Injury ]A neuropsychological test battery is designed to evaluate the cognitive domains commonly affected in survivors of moderate to severe TBI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810222
|ASST- Papa Giovanni XXIII|
|Bergamo, Italy, 24127|
|Principal Investigator:||PAOLO GRITTI, MD||ASST- Papa Giovanni XXIII|
|Study Chair:||FRANCESCO BIROLI, MD||Fondazione per la Ricerca Ospedale di Bergamo (FROM)|