Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03810222
Other study ID # TBI-PRO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 18, 2017
Est. completion date January 31, 2020

Study information

Verified date February 2021
Source Fondazione per la Ricerca Ospedale Maggiore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Italy ASST- Papa Giovanni XXIII Bergamo

Sponsors (1)

Lead Sponsor Collaborator
Fondazione per la Ricerca Ospedale Maggiore

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 12 Months Post-Injury
Secondary 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. 6 Months Post-Injury
Secondary Neuropsychological evaluation A neuropsychological test battery is designed to evaluate the cognitive domains commonly affected in survivors of moderate to severe TBI. 12 Months Post-Injury
See also
  Status Clinical Trial Phase
Recruiting NCT04111549 - GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth N/A
Recruiting NCT05097261 - Ketamine in Acute Brain Injury Patients. Phase 4
Completed NCT03504709 - REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Completed NCT05057377 - Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
Withdrawn NCT02776488 - Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI) Phase 2
Completed NCT02426749 - Treatment and Recovery Monitoring of Post TBI Symptoms N/A
Completed NCT01339702 - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Recruiting NCT05977270 - The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury N/A
Recruiting NCT04666766 - Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers N/A
Active, not recruiting NCT04559724 - Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes N/A
Not yet recruiting NCT04515420 - The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
Not yet recruiting NCT05569993 - Glutamine and Traumatic Brain Injury Early Phase 1
Recruiting NCT04331392 - Online Memory Intervention for Individuals With Traumatic Brain Injury N/A
Completed NCT03727737 - Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Completed NCT01336413 - Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans Phase 2
Completed NCT02004080 - CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Completed NCT04957563 - Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia N/A
Completed NCT05179330 - Visual Feedback in Lower Limb Rehabilitation N/A