Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

Mario Negri Institute for Pharmacological Research

Status: Enrolling

Conditions: Brain Injuries, Acute

Study type: Observational

Funder types: Other

Identifiers

NCT04905264

TIRESIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with Serious Acquired Brain Injuries
• admission to rehabilitation units

Exclusion criteria

• patients admitted more than 14 weeks after the acute event

Trial design

2,500 participants in 1 patient group

Adults admitted in participating Rehabilitation Units for Severe Acquired Brain Injuries

Description:

Adults admitted in study's participants Rehabilitation Units for Severe Acquired Brain Injuries from the 1st of July 2021 to the 31st of December 2023. Patients entered into these units more than 14 weeks after the acute event are excluded