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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03810222
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : February 1, 2019
Information provided by (Responsible Party):
Fondazione per la Ricerca Ospedale Maggiore

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).

Condition or disease Intervention/treatment
Brain Injuries, Traumatic Brain Injury Traumatic Moderate Brain Injury Traumatic Severe 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.

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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury in Bergamo Area (Italy)
Actual Study Start Date : January 18, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: N/A (Observational Study)
    This is an observational study and does not include interventions. Exposure is TBI.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03810222

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Contact: PIER LUIGI CARRIERO, MD +390352675134
Contact: ROSALIA ZANGARI, PhD +390352675134

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ASST- Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Contact: PAOLO GRITTI, MD    + 390352675134   
Sponsors and Collaborators
Fondazione per la Ricerca Ospedale Maggiore
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Principal Investigator: PAOLO GRITTI, MD ASST- Papa Giovanni XXIII
Study Chair: FRANCESCO BIROLI, MD Fondazione per la Ricerca Ospedale di Bergamo (FROM)

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Responsible Party: Fondazione per la Ricerca Ospedale Maggiore Identifier: NCT03810222     History of Changes
Other Study ID Numbers: TBI-PRO
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione per la Ricerca Ospedale Maggiore:
TBI moderate, TBI severe, GOSE
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System