Trials / Completed
CompletedNCT03810222
A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury
A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury in Bergamo Area (Italy)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 225 (actual)
- Sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
All patients admitted to the ICU with a diagnosis of moderate-to-severe TBI, with or without polytrauma, are recruited. Bergamo hospital is the main Trauma Centre (Level I) and the only referring neurosurgical center within a population of 1.2 million inhabitants of Bergamo area. This hospital is also a Regional Pediatric Trauma Centre.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | N/A (Observational Study) | This is an observational study and does not include interventions. Exposure is TBI. |
Timeline
- Start date
- 2017-01-18
- Primary completion
- 2020-01-31
- Completion
- 2020-01-31
- First posted
- 2019-01-18
- Last updated
- 2021-02-24
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03810222. Inclusion in this directory is not an endorsement.