Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

Brain Injuries, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905264
• Other study ID #: TIRESIA
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Acute
• Wounds and Injuries

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