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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Locations | 27 sites (Alessandria and 26 other locations) |
| Status | Recruiting |
| Started | January 3, 2022 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT04905264 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
- Study coordinator: Giulia Irene Ghilardi
- Email: giulia_irene.ghilardi@marionegri.it
- Phone: 035 4535389
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Hyperacute Neurobiomarker Kinetics in Acute Brain Injury: What Happens in Minutes After Injury
This study tests how early brain injury biomarkers behave in the first minutes to hours after traumatic brain injury or cardiac arrest to see if they rise quickly enough to help with early care.
-
Examining brain injury markers in patients after cardiac arrest
This study is trying to see if certain brain injury markers in the fluid around the brain and in the blood can help predict how well patients will recover after cardiac arrest.
-
Assessing mental health risks in adolescents with mild traumatic brain injury
This study is trying to create a tool that helps doctors predict which teens aged 11 to 17 who have had a mild brain injury might develop new or worsening mental health issues.
-
Co-designed wrist-hand orthosis for children with neuromotor disorders
In children aged 6 to 14 with neuromotor conditions after brain injury, researchers are testing a wrist-hand brace designed with input from the kids to see if it fits better and is easier to use than their current orthosis.
-
Portable MRI for kids with hypoxic brain injury
This study tests whether a bedside, low-field portable MRI can accurately detect hypoxic-ischemic brain injuries in children compared with standard imaging.
-
Monitoring beta-lactam antibiotics and kidney clearance in ICU patients with acute brain injury
This project tries to see if checking kidney clearance together with blood drug levels can quickly identify ICU patients with acute brain injury who need higher doses of beta-lactam antibiotics.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.