NCT04905264

Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this project is to identify the medium-term prognostic factors for patients with Severe Acquired Brain Injuries and evaluate their impact. The secondary aim is to create a system of continuous assessment of the quality of care for each rehabilitation unit.

Detailed description

For each unit involved, it will be collected these data : * Structural and organizational data of the Rehabilitation Units for Severe Acquired Brain Injuries; * Detailed information on patients upon entering Rehabilitation Units for Severe Acquired Brain Injuries; * Detailed information on patients, re-evaluated 4 months after the acute event Statistical models will be implemented, in order to identify prognostic factors that could predict the probability to observe three events, which represent objectives of the rehabilitation process: decannulation, trunk control and total feeding by os. These events should be evaluated four months after the acute episode.

Conditions

• Brain Injuries, Acute

Timeline

• Start date: 2022-01-03
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2021-05-27
• Last updated: 2025-08-13

Locations

27 sites across 1 country: Italy