Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

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.

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Key information

Conditions

Brain Injuries, Acute Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale SS. Antonio e Biagio e C. Arrigo, Alessandria, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with Serious Acquired Brain Injuries
admission to rehabilitation units

Exclusion criteria

patients admitted more than 14 weeks after the acute event

Treatment and study plan

Primary outcomes

Tracheostomy tube

Time frame: 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

Time frame: 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

Time frame: july 2021 - june 2025

Oral feeding with sufficient caloric intake

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Irene Ghilardi

CONTACT

[email protected]

035 4535389

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: May 27, 2021
Registry last updated: Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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