Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

NCT ID: NCT04905264

Last Updated: 2025-08-13

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-03

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Brain Injuries, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

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

Exclusion Criteria

\- patients admitted more than 14 weeks after the acute event
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Centro di Riabilitazione Terranuova Bracciolini

Arezzo, , Italy

Site Status RECRUITING

Ospedale civile di Baggiovara

Baggiovara, , Italy

Site Status RECRUITING

ASST Papa Giovanni XXIII

Bergamo, , Italy

Site Status RECRUITING

Ospedale Maggiore

Bologna, , Italy

Site Status RECRUITING

Fondazione Poliambulanza

Brescia, , Italy

Site Status RECRUITING

Ospedale S. Michele, AO Brotzu

Cagliari, , Italy

Site Status ACTIVE_NOT_RECRUITING

Ospedale S. Sebastiano

Correggio, , Italy

Site Status RECRUITING

Istituto S. Anna

Crotone, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, , Italy

Site Status RECRUITING

Fondazione Don Gnocchi

Florence, , Italy

Site Status RECRUITING

Ospedale di Foligno

Foligno, , Italy

Site Status NOT_YET_RECRUITING

Montecatone Rehabilitation Institute SpA

Imola, , Italy

Site Status RECRUITING

USL Toscana Nord Ovest

Lucca, , Italy

Site Status RECRUITING

IRCCS S. Maria Nascente, Fondazione don Gnocchi

Milan, , Italy

Site Status RECRUITING

Istituto Palazzolo, Don Gnocchi

Milan, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Sacro Cuore don Calabria

Negrar, , Italy

Site Status RECRUITING

ATS Sardegna

Oristano, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Buccheri La Ferla Fatebenefratelli

Palermo, , Italy

Site Status NOT_YET_RECRUITING

Centro Cardinal Ferrari

Parma, , Italy

Site Status NOT_YET_RECRUITING

AUSL Piacenza

Piacenza, , Italy

Site Status RECRUITING

Centro di riabilitazione E. Spalenza, Don Gnocchi

Rovato, , Italy

Site Status RECRUITING

Ospedale "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, , Italy

Site Status RECRUITING

Fondazione Don Gnocchi, Sant'Angelo dei Lombardi

Sant'Angelo dei Lombardi, , Italy

Site Status RECRUITING

IRCCS Telese, ICS Maugeri

Telese Terme, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Riabilitativo Villa Rosa

Trento, , Italy

Site Status RECRUITING

A.ULSS n.8 Berica

Vicenza, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giulia Irene Ghilardi

Role: CONTACT

035 4535389

Facility Contacts

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Luca Perrero

Role: primary

Cristiano Scarselli

Role: primary

Carmen Gambarelli

Role: primary

Silvia Galeri, MD

Role: primary

Serena Monteleone, MD

Role: backup

Emanuela Casanova

Role: primary

Chiara Mulè

Role: primary

Francesco Lombardi

Role: primary

Lucia Francesca Lucca

Role: primary

Susanna Lavezzi

Role: primary

Bahia Hakiki, MD

Role: primary

Federico Scarponi

Role: primary

Pamela Salucci, MD

Role: primary

Federico Posteraro

Role: primary

Jorge Navarro

Role: primary

Guya Devalle

Role: primary

Elena Rossato

Role: primary

Marta Carta

Role: primary

Giorgio MandalĂ 

Role: primary

Antonio De Tanti

Role: primary

Gianfranco Lamberti, MD

Role: primary

Marina Rossi

Role: primary

Domenico Intiso, MD

Role: primary

Anna Estraneo, MD

Role: primary

Bernardo Lanzillo

Role: primary

Michele Acler

Role: primary

Giannettore Bertagnoni

Role: primary

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.

Reference Type DERIVED
PMID: 40046674 (View on PubMed)

Other Identifiers

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TIRESIA

Identifier Type: -

Identifier Source: org_study_id

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