- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06183749
Predictors of Mortality in Traumatic Brain Injury Patients in Intensive Care Unit
Predictors of Mortality in Patients With Traumatic Brain Injury in the Tertiary Intensive Care Unit
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- trauma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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