Predictors of Mortality in Traumatic Brain Injury Patients in Intensive Care Unit

December 21, 2023 updated by: Senay Goksu, Umraniye Education and Research Hospital

Predictors of Mortality in Patients With Traumatic Brain Injury in the Tertiary Intensive Care Unit

The primary outcome of this study was to identify mortality predictors/risk factors affecting mortality and secondary outcome was to determine the distribution of brain injury types and other parameters according to type of trauma in patients with TBI treated in anesthesia-reanimation tertiary ICU.

Study Overview

Detailed Description

Patients with traumatic brain injury (TBI), especially severe cases are referred to neurotrauma centers where they are managed in neurosurgery intensive care units (ICU) or anesthesia-reanimation intensive care units as in Turkey. Such patients comprise a significant portion of patients managed in ICU with high rates of mortality and morbidity even with the best medical and neurosurgical care. It is crucial to identify the factors that contribute to mortality for TBI as it has a high incidence rate with significant mortality and morbidity.The aim of this study was to identify mortality predictors/risk factors affecting mortality and was to assess the distribution of brain injury in patients with TBI in anesthesia-reanimation ICU.

After receiving approval from the institutional Ethics Committee, we retrospectively identified patients over the age of 18 who were diagnosed with TBI by neurosurgery in the emergency department and were hospitalized in the 3rd stage Anesthesiology and Reanimation-ICU for more than 24 hours, within the last two-years period, using hospital computer records. They were then included in our studyThe patients were evaluated in 2 groups according to etiology as head trauma accompanied by general body trauma (Group 1) and isolated head trauma (Group 2).

Types of brain injury/hemorrhage due to head trauma were determined as intracerebral hemorrhage (ICH), subdural hematoma (SDH), epidural hematoma (EDH), traumatik subarachnoid hemorrhage (tSAH), cerebral contusion-diffuse axonal injury (DAI), and hemorrhages in which two or more of these conditions were combined (MIX).

Parameters included; age, sex, GCS at admission, APACHE II score, estimated mortality, actual mortality, type of brain injury, presence or absence of surgical intervention, presence or absence of skull fracture, length of ICU stay, duration of intubation, presence or absence of sedation, presence or absence of tracheotomy and outcome of disease. All data regarding above-mentioned parameters were extracted from patient files and electronic database.

It was aimed to assess relationship between mortality and parameters such as age, sex, surgical intervention, type of brain injury, duration of intubation, duration in ICU, GCS score and APACHE II scores, skull fracture in cases with TBI as primary outcome, it was also aimed to determine the distribution of etiology and these parameters over the TBI patients as secondary outcome.

As surgical intervention, operations with indications of bleeding control and/or control of intracranial pressure performed by neurosurgery department were taken into consideration for analysis.

In all patients, diagnosis was made based on CT scan and/or MR imaging study obtained at arrival to emergency department as a part of emergency protocol.

Study Type

Observational

Enrollment (Estimated)

194

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

patients over the age of 18, diagnosed as traumatic brain injury by neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit

Description

Inclusion Criteria:

  • patients over the age of 18,
  • diagnosed as traumatic brain injury by neurosurgery in the emergency department .hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit

Exclusion Criteria:

Failure to obtain institutional Ethics Committee approval Failure to obtain patients records

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
group 1general body trauma (Group 1)
Diagnosed as traumatic brain injury due to general body trauma neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit and those who have been in intensive care within the past two years.
diagnosed as traumatic brain injury by neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit and receivied appropriate necessary treatment
isolated head trauma (Group 2).
diagnosed as traumatic brain injury due isolated head trauma neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit and those who have been in intensive care within the past two years.
diagnosed as traumatic brain injury by neurosurgery in the emergency department and hospitalized for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit and receivied appropriate necessary treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality predictor
Time Frame: through study completion, an average of 2 months
Identification of those that are associated with mortality among the parameters examined
through study completion, an average of 2 months

Collaborators and Investigators

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

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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, Traumatic

Clinical Trials on hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit

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