Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

NCT04905264 · tracked via the Priya Life Science Italy tracker

Sponsor

Mario Negri Institute for Pharmacological Research

Phase

Observational

Started

2022-01-03

Last updated

2025-08-13

Condition(s) studied

Brain Injuries, Acute

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * patients with Serious Acquired Brain Injuries * admission to rehabilitation units Exclusion Criteria: \- patients admitted more than 14 weeks after the acute event

Primary outcome measure(s)

Tracheostomy tube — july 2021 - june 2025
Removal of the tracheostomy tube, which is considered successful if the patient is not to be re-cannulated within 7 days
Trunk control — july 2021 - june 2025
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
Total feeeding by os — july 2021 - june 2025
Oral feeding with sufficient caloric intake

Trial sites (27)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04905264 on ClinicalTrials.gov ↗ ← All trials in Italy