Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
NCT ID: NCT04905264
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2500 participants
OBSERVATIONAL
2022-01-03
2027-06-30
Brief Summary
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The secondary aim is to create a system of continuous assessment of the quality of care for each rehabilitation unit.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* admission to rehabilitation units
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Responsible Party
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Principal Investigators
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Guido Bertolini
Role: STUDY_CHAIR
Istituto Di Ricerche Farmacologiche Mario Negri
Locations
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Ospedale SS. Antonio e Biagio e C. Arrigo
Alessandria, , Italy
Centro di Riabilitazione Terranuova Bracciolini
Arezzo, , Italy
Ospedale civile di Baggiovara
Baggiovara, , Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
Ospedale Maggiore
Bologna, , Italy
Fondazione Poliambulanza
Brescia, , Italy
Ospedale S. Michele, AO Brotzu
Cagliari, , Italy
Ospedale S. Sebastiano
Correggio, , Italy
Istituto S. Anna
Crotone, , Italy
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, , Italy
Fondazione Don Gnocchi
Florence, , Italy
Ospedale di Foligno
Foligno, , Italy
Montecatone Rehabilitation Institute SpA
Imola, , Italy
USL Toscana Nord Ovest
Lucca, , Italy
IRCCS S. Maria Nascente, Fondazione don Gnocchi
Milan, , Italy
Istituto Palazzolo, Don Gnocchi
Milan, , Italy
Ospedale Sacro Cuore don Calabria
Negrar, , Italy
ATS Sardegna
Oristano, , Italy
Ospedale Buccheri La Ferla Fatebenefratelli
Palermo, , Italy
Centro Cardinal Ferrari
Parma, , Italy
AUSL Piacenza
Piacenza, , Italy
Centro di riabilitazione E. Spalenza, Don Gnocchi
Rovato, , 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, , Italy
Ospedale Riabilitativo Villa Rosa
Trento, , Italy
A.ULSS n.8 Berica
Vicenza, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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TIRESIA
Identifier Type: -
Identifier Source: org_study_id
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