Brain Injuries, TraumaticTBI-PRONCT03810222
A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic and Brain Injury Traumatic Moderate, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Injuries, Traumatic, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe
- What is being tested?
- N/A (Observational Study)
- How many people
- 225 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2017to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- admission to ICU
- diagnosis of moderate-to-severe TBI
Who cannot join
- Patients who died in the first couple of hours after hospital admission are not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- N/A (Observational Study)
- Keywords
- TBI moderate, TBI severe, GOSE
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A (Observational Study)Other
This is an observational study and does not include interventions. Exposure is TBI.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 Months Post-Injury
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 Months Post-Injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start18 Jan 2017
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PAOLO GRITTI, MD, Principal investigator, ASST- Papa Giovanni XXIIIFRANCESCO BIROLI, MD, Study chair, Fondazione per la Ricerca Ospedale di Bergamo (FROM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810222
- Sponsor's protocol ID
- TBI-PRO
- Acronym
- TBI-PRO
- Status last verified
- Feb 2021
- First submitted
- 16 Jan 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury in Bergamo Area (Italy)
- ClinicalTrials.gov ID
- NCT03810222
- Acronym / sponsor ID
- TBI-PRO / TBI-PRO
- Keywords
- TBI moderate, TBI severe, GOSE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- admission to ICU
- diagnosis of moderate-to-severe TBI
Key exclusion criteria (1 listed)
- Patients who died in the first couple of hours after hospital admission are not included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A (Observational Study)This is an observational study and does not include interventions. Exposure is TBI. | Other | – |
Primary outcome
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).
2 secondary outcomes
6-Month Outcome
Time frame: 6 Months Post-Injury
Neuropsychological evaluation
Time frame: 12 Months Post-Injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PAOLO GRITTI, MD principal investigator
ASST- Papa Giovanni XXIII
FRANCESCO BIROLI, MD study chair
Fondazione per la Ricerca Ospedale di Bergamo (FROM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic and Brain Injury Traumatic Moderate, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale - Extended (GOSE) (time frame: 12 Months Post-Injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.