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

NCT ID: NCT03810222

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2020-01-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

N/A (Observational Study)

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PAOLO GRITTI, MD

Role: PRINCIPAL_INVESTIGATOR

ASST- Papa Giovanni XXIII

FRANCESCO BIROLI, MD

Role: STUDY_CHAIR

Fondazione per la Ricerca Ospedale di Bergamo (FROM)

Locations

ASST- Papa Giovanni XXIII

Bergamo, , Italy

Countries

Italy

Other Identifiers

TBI-PRO

Identifier Type: -

Identifier Source: org_study_id