Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

Recruiting

• Conditions: Brain Injuries, Acute

• Registration Number: NCT04905264
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Study Start: 2022-01-03
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-08
• Last Update Posted: 2025-08-13
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total feeeding by os	july 2021 - june 2025	Oral feeding with sufficient caloric intake
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

Trial Locations

Locations (27)

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

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