Brain Injuries, AcuteNCT04905264
Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
An observational study of Brain Injuries, Acute, run by Mario Negri Institute for Pharmacological Research at 27 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Acute
- How many people
- 2,500 participants
- Where
- 27 sitesItaly
- Study dates
- 3 Jan 2022to Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients with Serious Acquired Brain Injuries
- admission to rehabilitation units
Who cannot join
- patients admitted more than 14 weeks after the acute event
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
Italy27 sites, 26 recruiting
- Recruiting
Ospedale SS. Antonio e Biagio e C. Arrigo
Alessandria, 15121
Luca Perrero, lperrero@ospedale.al.it
- Recruiting
Centro di Riabilitazione Terranuova Bracciolini
Arezzo, 52025
Cristiano Scarselli, cristiano.scarselli@gmail.com
- Recruiting
Ospedale civile di Baggiovara
Baggiovara, 41126
Carmen Gambarelli, gambarelli.carmen@aou.mo.it
- Recruiting
ASST Papa Giovanni XXIII
Bergamo
Silvia Galeri, MD, sgaleri@asst-pg23.it
Serena Monteleone, MD, smonteleone@asst-pg23.it
- Recruiting
Ospedale Maggiore
Bologna, 40133
Emanuela Casanova, e.casanova@isnb.it
- Recruiting
Fondazione Poliambulanza
Brescia, 25124
Chiara Mulè, chiara.mule@poliambulanza.it
- Active, not recruiting
Ospedale S. Michele, AO Brotzu
Cagliari, 09047
- Recruiting
Ospedale S. Sebastiano
Correggio, 42015
Francesco Lombardi, Francesco.Lombardi@ausl.re.it
- Recruiting
Istituto S. Anna
Crotone, 88900
Lucia Francesca Lucca, l.lucca@istitutosantanna.it
- Recruiting
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, 44124
Susanna Lavezzi, s.lavezzi@ospfe.it
- Recruiting
Fondazione Don Gnocchi
Florence
Bahia Hakiki, MD, bhakiki@dongnocchi.it
- Not yet recruiting
Ospedale di Foligno
Foligno, 06034
Federico Scarponi, scarponifede@gmail.com
- Recruiting
Montecatone Rehabilitation Institute SpA
Imola
Pamela Salucci, MD, pamela.salucci@montecatone.com
- Recruiting
USL Toscana Nord Ovest
Lucca, 55100
Federico Posteraro, federico.posteraro@uslnordovest.toscana.it
- Recruiting
IRCCS S. Maria Nascente, Fondazione don Gnocchi
Milan, 20148
Jorge Navarro, jnavarro@dongnocchi.it
- Not yet recruiting
Istituto Palazzolo, Don Gnocchi
Milan, 20149
Guya Devalle, gdevalle@dongnocchi.it
- Recruiting
Ospedale Sacro Cuore don Calabria
Negrar, 37024
Elena Rossato, elena.rossato@sacrocuore.it
- Not yet recruiting
ATS Sardegna
Oristano, 09170
Marta Carta, marta.carta@atssardegna.it
- Not yet recruiting
Ospedale Buccheri La Ferla Fatebenefratelli
Palermo, 90123
Giorgio Mandalà, mandala.giorgio@fbfpa.it
- Not yet recruiting
Centro Cardinal Ferrari
Parma, 43012
Antonio De Tanti, antonio.detanti@centrocardinalferrari.it
- Recruiting
AUSL Piacenza
Piacenza
Gianfranco Lamberti, MD, G.Lamberti2@ausl.pc.it
- Recruiting
Centro di riabilitazione E. Spalenza, Don Gnocchi
Rovato, 25038
Marina Rossi, marirossi@dongnocchi.it
- Recruiting
Ospedale "Casa Sollievo della Sofferenza"
San Giovanni Rotondo
Domenico Intiso, MD, d.intiso@operapadrepio.it
- Recruiting
Fondazione Don Gnocchi, Sant'Angelo dei Lombardi
Sant'Angelo dei Lombardi
Anna Estraneo, MD, aestraneo@gmail.com
- Not yet recruiting
IRCCS Telese, ICS Maugeri
Telese Terme, 82037
Bernardo Lanzillo, bernardo.lanzillo@icsmaugeri.it
- Recruiting
Ospedale Riabilitativo Villa Rosa
Trento, 38057
Michele Acler, michele.acler@apss.tn.it
- Recruiting
A.ULSS n.8 Berica
Vicenza, 36100
Giannettore Bertagnoni, giannettore.bertagnoni@aulss8.veneto.it
About this study
Official title: TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
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.
Read the 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.
- Conditions
- Brain Injuries, Acute
- Keywords
- Rehabilitation, Brain Injuries
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheostomy tube
Removal of the tracheostomy tube, which is considered successful if the patient is not to be re-cannulated within 7 days
Measured: 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
Measured: july 2021 - june 2025
Total feeeding by os
Oral feeding with sufficient caloric intake
Measured: july 2021 - june 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start3 Jan 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Bertolini, Study chair, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905264
- Sponsor's protocol ID
- TIRESIA
- Status last verified
- Oct 2026
- First submitted
- 24 May 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protecting the privacy policy, all the data that underlie results in a publication will be shared. The scientific commettee of the study has to decide the criteria and the best way to share them
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. 2025 Feb 19;16:1527533. doi: 10.3389/fneur.2025.1527533. eCollection 2025.
PubMed 40046674