Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04905264

Enrollment

2500

Registered

2021-05-27

Start date

2022-01-03

Completion date

2027-06-30

Last updated

2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Acute

Keywords

Rehabilitation, Brain Injuries

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Tracheostomy tube	july 2021 - june 2025	Removal of the tracheostomy tube, which is considered successful if the patient is not to be re-cannulated within 7 days
Trunk control	july 2021 - june 2025	Achievement of trunk control, for which the patient must be able to maintain the sitting position for at least 60 seconds, on a rigid surface, with the lower limbs in support, but without support from the upper limbs and without rear support of the trunk
Total feeeding by os	july 2021 - june 2025	Oral feeding with sufficient caloric intake

Countries

Italy

Contacts

Primary ContactGiulia Irene Ghilardi

giulia_irene.ghilardi@marionegri.it035 4535389

Outcome results