A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury (TBI-PRO)

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

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).

Study Overview

• Status: Completed
• Conditions: Brain Injuries, Traumatic; Brain Injury Traumatic Severe; Brain Injury Traumatic Moderate
• Intervention / Treatment: Other: N/A (Observational Study)

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 Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • ASST- Papa Giovanni XXIII

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU with a diagnosis of moderate (Glasgow Coma Scale, GCS 9-13) or severe TBI (GCS 3-8), with or without associated polytrauma. Patients transferred from other hospitals within the first 24h are included.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fondazione per la Ricerca Ospedale Maggiore
• Investigators: Study Chair: Francesco Biroli, MD, Fondazione per la Ricerca Ospedale di Bergamo (FROM); Principal Investigator: PAOLO GRITTI, MD, ASST- Papa Giovanni XXIII

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: TBI moderate, TBI severe, GOSE
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: TBI-PRO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No