Mortality in Brain Injury at the Intensive Care Unit (TraVi II) (TraVi_II)

January 13, 2025 updated by: Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

Factors Associated With Mortality in Brain Injury at the Intensive Care Unit. A Cross-sectional Trial, 2019-2023 (TraVi II)

Introduction: traumatic brain injuries are a leading cause of disability and mortality in the young population, associated mainly with traffic road accidents and violent wounds. The study aimed to analyze factors related to the mortality in patients with brain injury admitted to the intensive care unit.

Methodology: Between 2019 and 2024, an analytical cross-sectional trial at Hospital Departamental de Villavicencio, Colombia was performed. Information was selected from the intensive care unit (ICU) database. Variables of interest and outcomes, such as mortality and ICU length of stay, were identified. The comparison was performed with the software Prism® for Mac iOS and Wizard® for the predictive model.

Results: The study will show the factors associated with mortality of brain injury patients admitted to the intensive care unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: The study aimed to analyze factors related to the mortality in patients with brain injury admitted to the intensive care unit.

Methodology: Between 2019 and 2024, an analytical cross-sectional trial at Hospital Departamental de Villavicencio, Colombia, a reference center for the Colombian Orinoco region with 400 hospital beds and 53 polyvalent ICU beds was performed. Information was selected from 2,154 admission registers in the intensive care unit (ICU) database. Data of admissions considered for review were from patients with diagnostic codes of brain injury, brain edema, polytrauma, ventilatory failure, neurogenic shock, and traumatic subarachnoid hemorrhage. All the registries with codes S00-S09 from the 10th revision of the International Diseases Classification from the World Health Organization were reviewed. Variables of interest and outcomes, such as mortality and ICU length of stay, were identified. The comparison was performed with the software Prism® for Mac iOS and Wizard® for the predictive model.

Results: The study will show the factors associated with mortality of brain injury patients admitted to the intensive care unit.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

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

Study Locations

  • Colombia
    • Meta
      • Villavicencio, Meta, Colombia, 50001
        • Hospital Departamental de Villavicencio

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population was patients with traumatic brain injury who were admitted to the intensive care unit.

Description

Inclusion Criteria:

  • Traumatic brain injury.
  • Admitted to the intensive care unit.

Exclusion Criteria:

  • Remission from another hospital.
  • Decease for causes other than the brain injury.

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
Intervention / Treatment
Mortality
Survival
Other: Risk factor present
Demographic, and severity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: 30 days
Mortality at the ICU
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: 30 days
Length of stay at the intensive care unit.
30 days

Collaborators and Investigators

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

Sponsor

Hospital Departamental de Villavicencio

Investigators

  • Principal Investigator: Norton Perez, MD, Hospital Departamental de Villavicencio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2019

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIVI_2024_01_TCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It contains sensible information about patients.

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.

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