Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care

March 12, 2024 updated by: Mario Negri Institute for Pharmacological Research

TIRESIA Project - 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients admitted in the Rehabilitation Units for Severe Acquired Brain Injuries participating in the study during the 30 months of enrollment provided by the research

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adults admitted in participating Rehabilitation Units for Severe Acquired Brain Injuries
Adults admitted in study's participants Rehabilitation Units for Severe Acquired Brain Injuries from the 1st of July 2021 to the 31st of December 2023. Patients entered into these units more than 14 weeks after the acute event are excluded

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
july 2021 - june 2025
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
july 2021 - june 2025
Total feeeding by os
Time Frame: july 2021 - june 2025
Oral feeding with sufficient caloric intake
july 2021 - june 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mario Negri Institute for Pharmacological Research

Investigators

  • Study Chair: Guido Bertolini, Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIRESIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Protecting the privacy policy, all the data that underlie results in a publication will be shared. The scientific commettee of the study has to decide the criteria and the best way to share them

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Injuries, Acute

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe