Clinical trial NCT04905264: Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
Official title: TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injuries, Acute
Keywords: Rehabilitation
Brain Injuries
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

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

Primary outcomes:
measure: Tracheostomy tube
timeFrame: july 2021 - june 2025
measure: Trunk control
timeFrame: july 2021 - june 2025
measure: Total feeeding by os
timeFrame: july 2021 - june 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ospedale SS. Antonio e Biagio e C. Arrigo
city: Arezzo
country: Italy
facility: Centro di Riabilitazione Terranuova Bracciolini
city: Baggiovara
country: Italy
facility: Ospedale civile di Baggiovara
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Cagliari
country: Italy
facility: Ospedale S. Michele, AO Brotzu
city: Correggio
country: Italy
facility: Ospedale S. Sebastiano
city: Crotone
country: Italy
facility: Istituto S. Anna
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
city: Firenze
country: Italy
facility: Fondazione Don Gnocchi
city: Foligno
country: Italy
facility: Ospedale di Foligno
city: Imola
country: Italy
facility: Montecatone Rehabilitation Institute SpA
city: Lucca
country: Italy
facility: USL Toscana Nord Ovest
city: Milano
country: Italy
facility: IRCCS S. Maria Nascente, Fondazione don Gnocchi
city: Milano
country: Italy
facility: Istituto Palazzolo, Don Gnocchi
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore don Calabria
city: Oristano
country: Italy
facility: ATS Sardegna
city: Palermo
country: Italy
facility: Ospedale Buccheri La Ferla Fatebenefratelli
city: Parma
country: Italy
facility: Centro Cardinal Ferrari
city: Piacenza
country: Italy
facility: AUSL Piacenza
city: Rovato
country: Italy
facility: Centro di riabilitazione E. Spalenza, Don Gnocchi
city: San Giovanni Rotondo
country: Italy
facility: Ospedale "Casa Sollievo della Sofferenza"
city: Sant'Angelo Dei Lombardi
country: Italy
facility: Fondazione Don Gnocchi, Sant'Angelo dei Lombardi
city: Telese Terme
country: Italy
facility: IRCCS Telese, ICS Maugeri
city: Trento
country: Italy
facility: Ospedale Riabilitativo Villa Rosa
city: Vicenza
country: Italy
facility: A.ULSS n.8 Berica
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Guido Bertolini
role: STUDY_CHAIR
References: