Clinical trial Recruiting at 20 sites Observational Ages 18 and up

Identifying Prognostic Factors and Quality of Care in Severe Brain Injuries

Official title: TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

Run by Mario Negri Institute for Pharmacological Research · NCT04905264 · Data updated 2026-11-12

This study is trying to find out what factors can help predict recovery for people with severe brain injuries and how these factors affect their rehabilitation progress.

More Brain Injuries trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2500 (estimated)
SponsorMario Negri Institute for Pharmacological Research
Academic / other
Locations27 sites (Alessandria and 26 other locations)
StatusRecruiting
StartedJanuary 3, 2022
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedOctober 9, 2026
Trial IDNCT04905264 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with severe acquired brain injuries who are admitted to rehabilitation units.

Probably not a fit

Patients who are admitted to rehabilitation units more than 14 weeks after the acute event may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to identify medium-term prognostic factors for patients with severe acquired brain injuries and assess their impact on rehabilitation outcomes. It involves collecting structural and organizational data from rehabilitation units, as well as detailed patient information upon admission and re-evaluation four months post-acute event. Statistical models will be used to predict the likelihood of achieving key rehabilitation objectives such as decannulation, trunk control, and total feeding by mouth.

Why it matters

Potential benefit: If successful, this study could enhance rehabilitation strategies and improve outcomes for patients with severe brain injuries.

How similar studies have gone: Other studies have shown success in identifying prognostic factors in brain injury rehabilitation, making this approach both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Ospedale SS. Antonio e Biagio e C. Arrigo
    Alessandria, Italy
    Recruiting
  • Centro di Riabilitazione Terranuova Bracciolini
    Arezzo, Italy
    Recruiting
  • Ospedale civile di Baggiovara
    Baggiovara, Italy
    Recruiting
  • ASST Papa Giovanni XXIII
    Bergamo, Italy
    Recruiting
  • Ospedale Maggiore
    Bologna, Italy
    Recruiting
  • Fondazione Poliambulanza
    Brescia, Italy
    Recruiting
Show 21 more locations
  • Ospedale S. Sebastiano
    Correggio, Italy
    Recruiting
  • Istituto S. Anna
    Crotone, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria di Ferrara
    Ferrara, Italy
    Recruiting
  • Fondazione Don Gnocchi
    Florence, Italy
    Recruiting
  • Montecatone Rehabilitation Institute SpA
    Imola, Italy
    Recruiting
  • USL Toscana Nord Ovest
    Lucca, Italy
    Recruiting
  • IRCCS S. Maria Nascente, Fondazione don Gnocchi
    Milan, Italy
    Recruiting
  • Ospedale Sacro Cuore don Calabria
    Negrar, Italy
    Recruiting
  • AUSL Piacenza
    Piacenza, Italy
    Recruiting
  • Centro di riabilitazione E. Spalenza, Don Gnocchi
    Rovato, Italy
    Recruiting
  • Ospedale "Casa Sollievo della Sofferenza"
    San Giovanni Rotondo, Italy
    Recruiting
  • Fondazione Don Gnocchi, Sant'Angelo dei Lombardi
    Sant'Angelo dei Lombardi, Italy
    Recruiting
  • Ospedale Riabilitativo Villa Rosa
    Trento, Italy
    Recruiting
  • A.ULSS n.8 Berica
    Vicenza, Italy
    Recruiting
  • Ospedale S. Michele, AO Brotzu
    Cagliari, Italy
    Active not recruiting
  • Ospedale di Foligno
    Foligno, Italy
    Not yet recruiting
  • Istituto Palazzolo, Don Gnocchi
    Milan, Italy
    Not yet recruiting
  • ATS Sardegna
    Oristano, Italy
    Not yet recruiting
  • Ospedale Buccheri La Ferla Fatebenefratelli
    Palermo, Italy
    Not yet recruiting
  • Centro Cardinal Ferrari
    Parma, Italy
    Not yet recruiting
  • IRCCS Telese, ICS Maugeri
    Telese Terme, Italy
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.