A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury

Completed

• Conditions: Brain Injury Traumatic Severe; Brain Injuries, Traumatic; Brain Injury Traumatic Moderate

• Registration Number: NCT03810222
• Lead Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Brief 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.

Study Timeline

• Study Start: 2017-01-18
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• admission to ICU
• diagnosis of moderate-to-severe TBI

Exclusion Criteria

Patients who died in the first couple of hours after hospital admission are not included.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale - Extended (GOSE)	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).

Secondary Outcome Measures

Name	Time	Method
Neuropsychological evaluation	12 Months Post-Injury	A neuropsychological test battery is designed to evaluate the cognitive domains commonly affected in survivors of moderate to severe TBI.
6-Month Outcome	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.

Trial Locations

Locations (1)

ASST- Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy