Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brain Injuries, Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
Overview
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.
Primary outcome measures
- Tracheostomy tube [Time frame: july 2021 - june 2025]
- Trunk control [Time frame: july 2021 - june 2025]
- Total feeeding by os [Time frame: july 2021 - june 2025]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 27 centers
- Ospedale SS. Antonio e Biagio e C. Arrigo — Alessandria
- Centro di Riabilitazione Terranuova Bracciolini — Arezzo
- Ospedale civile di Baggiovara — Baggiovara
- ASST Papa Giovanni XXIII — Bergamo
- Ospedale Maggiore — Bologna
- Fondazione Poliambulanza — Brescia
- Ospedale S. Michele, AO Brotzu — Cagliari
- Ospedale S. Sebastiano — Correggio
- … and 19 more centers
Publications
- Nattino G, Acler M, Bargellesi S, Bertagnoni G, Carrara G, De Tanti A, Estraneo A, Ghilardi GI, Lavezzi S, Lombardi F, Lucca LF, Mancuso M, Montis A, Mule C, Navarro J, Posteraro F, Rossato E, Simoncini L, Bertolini G. A prospective multicenter study on prognostic factors and quality of care in Severe Acquired Brain Injury rehabilitation units: a project from the Tiresia network. Front Neurol. 202 PMID 40046674
Identifiers
NCT: NCT04905264 · TIRESIA