Brain Injuries, Acute Clinical Trial
Official title:
TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
NCT number | NCT04905264 |
Other study ID # | TIRESIA |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 3, 2022 |
Est. completion date | June 30, 2025 |
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.
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients with Serious Acquired Brain Injuries - admission to rehabilitation units Exclusion Criteria: - patients admitted more than 14 weeks after the acute event |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale SS. Antonio e Biagio e C. Arrigo | Alessandria | |
Italy | Centro di Riabilitazione Terranuova Bracciolini | Arezzo | |
Italy | Ospedale civile di Baggiovara | Baggiovara | |
Italy | ASST Papa Giovanni XXIII | Bergamo | |
Italy | Ospedale Maggiore | Bologna | |
Italy | Fondazione Poliambulanza | Brescia | |
Italy | Ospedale S. Michele, AO Brotzu | Cagliari | |
Italy | Ospedale S. Sebastiano | Correggio | |
Italy | Istituto S. Anna | Crotone | |
Italy | Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | |
Italy | Fondazione Don Gnocchi | Firenze | |
Italy | Ospedale di Foligno | Foligno | |
Italy | Montecatone Rehabilitation Institute SpA | Imola | |
Italy | USL Toscana Nord Ovest | Lucca | |
Italy | IRCCS S. Maria Nascente, Fondazione don Gnocchi | Milano | |
Italy | Istituto Palazzolo, Don Gnocchi | Milano | |
Italy | Ospedale Sacro Cuore don Calabria | Negrar | |
Italy | ATS Sardegna | Oristano | |
Italy | Ospedale Buccheri La Ferla Fatebenefratelli | Palermo | |
Italy | Centro Cardinal Ferrari | Parma | |
Italy | AUSL Piacenza | Piacenza | |
Italy | Centro di riabilitazione E. Spalenza, Don Gnocchi | Rovato | |
Italy | Fondazione Don Gnocchi, Sant'Angelo dei Lombardi | Sant'Angelo Dei Lombardi | |
Italy | IRCCS Telese, ICS Maugeri | Telese Terme | |
Italy | Ospedale Riabilitativo Villa Rosa | Trento | |
Italy | A.ULSS n.8 Berica | Vicenza |
Lead Sponsor | Collaborator |
---|---|
Mario Negri Institute for Pharmacological Research |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tracheostomy tube | Removal of the tracheostomy tube, which is considered successful if the patient is not to be re-cannulated within 7 days | july 2021 - june 2025 | |
Primary | 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 | july 2021 - june 2025 | |
Primary | Total feeeding by os | Oral feeding with sufficient caloric intake | july 2021 - june 2025 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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