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OpenTrials
Completed

NCT Number: NCT03810222

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

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).

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Key information

Conditions

Brain Injuries, Traumatic Brain Diseases Brain Injuries Brain Injury Traumatic Moderate Brain Injury Traumatic Severe Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST- Papa Giovanni XXIII

Bergamo, 24127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N/A (Observational Study)

Other

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

Primary outcomes

  1. Glasgow Outcome Scale - Extended (GOSE)

    Time frame: 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 outcomes

  1. 6-Month Outcome

    Time frame: 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.

  2. Neuropsychological evaluation

    Time frame: 12 Months Post-Injury

    A neuropsychological test battery is designed to evaluate the cognitive domains commonly affected in survivors of moderate to severe TBI.

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Official study title

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

Acronym: TBI-PRO

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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