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ClinicalTrials.gov ID

NCT04905264

Lead Sponsor

Mario Negri Institute for Pharmacological ResearchOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

2,500Estimated

Last Update Posted

Aug 13, 2025Actual

Start Date

Jan 3, 2022Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

Official Title

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

Brief 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.

• Brain Injuries, Acute

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- patients admitted more than 14 weeks after the acute event

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Mario Negri Institute for Pharmacological ResearchOTHER

G.Lamberti2@ausl.pc.it