Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
1 other identifier
observational
2,500
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedStudy Start
First participant enrolled
January 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
August 13, 2025
August 1, 2025
5.4 years
May 24, 2021
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Tracheostomy tube
Removal of the tracheostomy tube, which is considered successful if the patient is not to be re-cannulated within 7 days
july 2021 - june 2025
Trunk control
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
july 2021 - june 2025
Total feeeding by os
Oral feeding with sufficient caloric intake
july 2021 - june 2025
Study Arms (1)
Adults admitted in participating Rehabilitation Units for Severe Acquired Brain Injuries
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
Eligibility Criteria
All patients admitted in the Rehabilitation Units for Severe Acquired Brain Injuries participating in the study during the 30 months of enrollment provided by the research
You may qualify if:
- patients with Serious Acquired Brain Injuries
- admission to rehabilitation units
You may not qualify if:
- \- patients admitted more than 14 weeks after the acute event
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Ospedale SS. Antonio e Biagio e C. Arrigo
Alessandria, 15121, Italy
Centro di Riabilitazione Terranuova Bracciolini
Arezzo, 52025, Italy
Ospedale civile di Baggiovara
Baggiovara, 41126, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
Ospedale Maggiore
Bologna, 40133, Italy
Fondazione Poliambulanza
Brescia, 25124, Italy
Ospedale S. Michele, AO Brotzu
Cagliari, 09047, Italy
Ospedale S. Sebastiano
Correggio, 42015, Italy
Istituto S. Anna
Crotone, 88900, Italy
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, 44124, Italy
Fondazione Don Gnocchi
Florence, Italy
Ospedale di Foligno
Foligno, 06034, Italy
Montecatone Rehabilitation Institute SpA
Imola, Italy
USL Toscana Nord Ovest
Lucca, 55100, Italy
IRCCS S. Maria Nascente, Fondazione don Gnocchi
Milan, 20148, Italy
Istituto Palazzolo, Don Gnocchi
Milan, 20149, Italy
Ospedale Sacro Cuore don Calabria
Negrar, 37024, Italy
ATS Sardegna
Oristano, 09170, Italy
Ospedale Buccheri La Ferla Fatebenefratelli
Palermo, 90123, Italy
Centro Cardinal Ferrari
Parma, 43012, Italy
AUSL Piacenza
Piacenza, Italy
Centro di riabilitazione E. Spalenza, Don Gnocchi
Rovato, 25038, Italy
Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, Italy
Fondazione Don Gnocchi, Sant'Angelo dei Lombardi
Sant'Angelo dei Lombardi, Italy
IRCCS Telese, ICS Maugeri
Telese Terme, 82037, Italy
Ospedale Riabilitativo Villa Rosa
Trento, 38057, Italy
A.ULSS n.8 Berica
Vicenza, 36100, Italy
Related Publications (1)
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. 2025 Feb 19;16:1527533. doi: 10.3389/fneur.2025.1527533. eCollection 2025.
PMID: 40046674DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guido Bertolini
Istituto Di Ricerche Farmacologiche Mario Negri
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2021
First Posted
May 27, 2021
Study Start
January 3, 2022
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
August 13, 2025
Record last verified: 2025-08