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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date December 2023
Source Mario Negri Institute for Pharmacological Research
Contact Giulia Irene Ghilardi
Phone 035 4535389
Email giulia_irene.ghilardi@marionegri.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

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
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