Identifying Prognostic Factors and Quality of Care in Severe Brain Injuries
TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Locations | 27 sites (Alessandria and 26 other locations) |
| Trial ID | NCT04905264 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with severe acquired brain injuries who are admitted to rehabilitation units.
Not a fit: Patients who are admitted to rehabilitation units more than 14 weeks after the acute event may not benefit from this study.
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 performed: Other studies have shown success in identifying prognostic factors in brain injury rehabilitation, making this approach both relevant and potentially impactful.
Eligibility criteria
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 this trial is running
Alessandria and 26 other locations
- 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)
- Ospedale S. Michele, AO Brotzu — Cagliari, Italy (Active_not_recruiting)
- 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)
- Ospedale di Foligno — Foligno, Italy (Not_yet_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)
- Istituto Palazzolo, Don Gnocchi — Milan, Italy (Not_yet_recruiting)
- Ospedale Sacro Cuore don Calabria — Negrar, Italy (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)
- 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)
- IRCCS Telese, ICS Maugeri — Telese Terme, Italy (Not_yet_recruiting)
- Ospedale Riabilitativo Villa Rosa — Trento, Italy (Recruiting)
- A.ULSS n.8 Berica — Vicenza, Italy (Recruiting)
Study contacts
- Study coordinator: Giulia Irene Ghilardi
- Email: giulia_irene.ghilardi@marionegri.it
- Phone: 035 4535389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.