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

NCT03810222 | Completed

• 1 other identifier: TBI-PRO
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Injuries, Traumatic; Brain Injury Traumatic Moderate; Brain Injury Traumatic Severe

Keywords

TBI moderate, TBI severe, GOSE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 6-Month Outcome

  6 Months Post-Injury

• Neuropsychological evaluation

  12 Months Post-Injury

Interventions

N/A (Observational Study) OTHER

This is an observational study and does not include interventions. Exposure is TBI.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead

Study Sites (1)

ASST- Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• PAOLO GRITTI, MD

  ASST- Papa Giovanni XXIII

  PRINCIPAL INVESTIGATOR

• FRANCESCO BIROLI, MD

  Fondazione per la Ricerca Ospedale di Bergamo (FROM)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: January 18, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

IT (1)