Brain Injuries, TraumaticNCT06183749
Predictors of Mortality in Traumatic Brain Injury Patients in Intensive Care Unit
An observational study of Brain Injuries, Traumatic, run by Umraniye Education and Research Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Failure to obtain institutional Ethics Committee approval Failure to obtain patients records
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit
- Keywords
- brain injuries, traumatic, mortality prediction
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unitOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit | |
| 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. Receives: Other: hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality predictor
Identification of those that are associated with mortality among the parameters examined
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Senay Goksu, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183749
- Sponsor's protocol ID
- trauma
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Mortality in Patients With Traumatic Brain Injury in the Tertiary Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06183749
- Acronym / sponsor ID
- trauma
- Conditions
- Brain Injuries, Traumatic
- Keywords
- brain injuries, traumatic, mortality prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Feb 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1general body trauma (Group 1) | – | Other: hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unitDiagnosed 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. |
| isolated head trauma (Group 2). | – | Other: hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unitdiagnosed 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to obtain institutional Ethics Committee approval Failure to obtain patients records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hospitalisation for more than 24 hours in the 3rd stage Anesthesiology and Reanimation unitdiagnosed 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 | Other | group 1general body trauma (Group 1), isolated head trauma (Group 2). |
Primary outcome
mortality predictor
Time frame: through study completion, an average of 2 months
Identification of those that are associated with mortality among the parameters examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Umraniye Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality predictor (time frame: through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.