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

Brain Injuries, Traumatic Clinical Trial

— TBI-PRO  

Official title:

A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury in Bergamo Area (Italy)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810222
• Other study ID #: TBI-PRO
• Status: Completed
• Start date: January 18, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2021
• Source: Fondazione per la Ricerca Ospedale Maggiore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Moderate
• Brain Injury Traumatic Severe
• Wounds and Injuries

Intervention

Other:
• N/A (Observational Study)
This is an observational study and does not include interventions. Exposure is TBI.

Locations

Country	Name	City	State
Italy	ASST- Papa Giovanni XXIII	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione per la Ricerca Ospedale Maggiore

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale - Extended (GOSE)	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).	12 Months Post-Injury
Secondary	6-Month Outcome	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.	6 Months Post-Injury
Secondary	Neuropsychological evaluation	A neuropsychological test battery is designed to evaluate the cognitive domains commonly affected in survivors of moderate to severe TBI.	12 Months Post-Injury