Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03810222
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione per la Ricerca Ospedale Maggiore

Tracking Information
First Submitted Date January 16, 2019
First Posted Date January 18, 2019
Last Update Posted Date February 1, 2019
Actual Study Start Date January 18, 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2019)
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).
Original Primary Outcome Measures
 (submitted: January 16, 2019)
Glasgow Outcome Scale - Extendend (GOSE) [ Time Frame: 12 Months Post-Injury ]
The global functional outcome at 12 months is assessed in survivors using the validated written questionnaire of Glasgow Outcome Scale-Extended (GOSE). The GOSE provides an overall 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. GOSE 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 ).
Change History Complete list of historical versions of study NCT03810222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 30, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: January 16, 2019)
  • Clinical and neuroradiological assessment [ Time Frame: 6 Months Post-Injury ]
    At the 6-month follow-up visit, patients have a GOSE evaluation, an MRI Brain scan (or CT) and a clinical assesment.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury
Official Title A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury in Bergamo Area (Italy)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Brain Injuries, Traumatic
  • Brain Injury Traumatic Moderate
  • Brain Injury Traumatic Severe
Intervention Other: N/A (Observational Study)
This is an observational study and does not include interventions. Exposure is TBI.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 16, 2019)
225
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: PIER LUIGI CARRIERO, MD +390352675134 pcarriero@asst-pg23.it
Contact: ROSALIA ZANGARI, PhD +390352675134 rzangari@asst-pg23.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03810222
Other Study ID Numbers TBI-PRO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Fondazione per la Ricerca Ospedale Maggiore
Study Sponsor Fondazione per la Ricerca Ospedale Maggiore
Collaborators Not Provided
Investigators
Principal Investigator: PAOLO GRITTI, MD ASST- Papa Giovanni XXIII
Study Chair: FRANCESCO BIROLI, MD Fondazione per la Ricerca Ospedale di Bergamo (FROM)
PRS Account Fondazione per la Ricerca Ospedale Maggiore
Verification Date January 2019