Multiple Trauma/InjuriesNCT07185529
Predictors of Mortality in Multiple Trauma Patients
An observational study of Multiple Trauma/Injuries, run by Melike Cengiz at 1 site in Turkey (Türkiye).
Trial summary
Trauma is a public health concern that causes serious financial and medical burdens worldwide. According to the World Health Organization, 4.4 million people die from traumatic injuries each year which account for about 8% of global deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Trauma/Injuries
- What is being tested?
- Data of the patients were obtained from patient observation files and hospital information system database.
- How many people
- 269 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 Jul 2025
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The sample included patients with multiple trauma injuries who were admitted in the ICU between 01 January 2021 and 01 November 2023.
Who may be able to join
- Patients aged ≥18 years with patients with multiple trauma injuries
- Patients with a final outcome (survival or mortality) in our centre
Who cannot join
- Patients with trauma to a single region (head, thorax, abdomen or extremities)
- Patients who were pregnant
- Length of intensive care unit stay ≤24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Mortality in Multiple Trauma Patients With Intensive Care Unit: A Retrospective Cohort Study
Trauma is a public health concern that causes serious financial and medical burdens worldwide. According to the World Health Organization, 4.4 million people die from traumatic injuries each year which account for about 8% of global deaths. Traumatic injuries are among the most common causes of mortality particularly in young individuals. It also has a negative economic impact due to the loss of labor. Determining the factors associated with mortality in the ICU follow-up and treatment of these patients is very important for clarifying these uncertainties and improving ICU outcomes. The main objective of the study was to ascertain the ICU processes of multipletrauma patients and the factors that may have an effect on mortality.
Read the detailed description
All patients with traumatic injuries severe enough to warrant ICU admission formed the subjects of the study. The study included patients aged 18 years and over who were diagnosed with multiple trauma injuries and admitted to the ICU.The analysis included patients with a final outcome (survival or death) at our centre. Only patients who were admitted to the ICU for the first time were included. The following systems were used to assess the clinical and multiple trauma injury severity at the time of admission to the ICU: the Acute Physiology and Chronic Health Assessment II (APACHE II) score, the Simplified Acute Physiology Score II (SAPS II), the Sequential Organ Failure Assessment (SOFA) score, the Glasgow Coma Scale (GCS), the Injury Severity Score (ISS), the Revised Trauma Score (RTS) and the Trauma and Injury Severity Score (TRISS). All injury severity scores were calculated using clinical findings, imaging results and surgical findings. A comprehensive data set was collated at the time of admission to the intensive care unit, encompassing patient age, gender, comorbidities, and the Charlson Comorbidity Index (CCI). The injury mechanism, blood sugar, haemoglobin and lactate levels, Horowitz index, hypotension and hypothermia were also recorded.The patients were categorised into two groups: survival and mortality
- Conditions
- Multiple Trauma/Injuries
- Being tested
- Data of the patients were obtained from patient observation files and hospital information system database.
- Keywords
- Intensive Care Unit, Mortality, Multiple trauma patient
- Medical subject headings
- Multiple Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data of the patients were obtained from patient observation files and hospital information system database.Other
Data of the patients were obtained from patient observation files and hospital information system database.
| Study group | Role | What they receive |
|---|---|---|
| survival | consists of surviving patients Receives: Other: Data of the patients were obtained from patient observation files and hospital information system database. | |
| mortality | consists of deceased patients Receives: Other: Data of the patients were obtained from patient observation files and hospital information system database. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is mortality
Measured: 01 January 2021 and 01 November 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jan 2021
- Primary completion1 Nov 2023
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Trauma/InjuriesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melike Cengiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melike Cengiz, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185529
- Sponsor's protocol ID
- Akdeniz.
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Mortality in Multiple Trauma Patients With Intensive Care Unit: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07185529
- Acronym / sponsor ID
- Akdeniz.
- Conditions
- Multiple Trauma/Injuries
- Keywords
- Intensive Care Unit, Mortality, Multiple trauma patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Melike CengizUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 22 Sep 2025 (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.
Trauma is a public health concern that causes serious financial and medical burdens worldwide. According to the World Health Organization, 4.4 million people die from traumatic injuries each year which account for about 8% of global deaths. Traumatic injuries are among the most common causes of mortality particularly in young individuals. It also has a negative economic impact due to the loss of labor. Determining the factors associated with mortality in the ICU follow-up and treatment of these patients is very important for clarifying these uncertainties and improving ICU outcomes. The main objective of the study was to ascertain the ICU processes of multipletrauma patients and the factors that may have an effect on mortality.
Detailed description
All patients with traumatic injuries severe enough to warrant ICU admission formed the subjects of the study. The study included patients aged 18 years and over who were diagnosed with multiple trauma injuries and admitted to the ICU.The analysis included patients with a final outcome (survival or death) at our centre. Only patients who were admitted to the ICU for the first time were included. The following systems were used to assess the clinical and multiple trauma injury severity at the time of admission to the ICU: the Acute Physiology and Chronic Health Assessment II (APACHE II) score, the Simplified Acute Physiology Score II (SAPS II), the Sequential Organ Failure Assessment (SOFA) score, the Glasgow Coma Scale (GCS), the Injury Severity Score (ISS), the Revised Trauma Score (RTS) and the Trauma and Injury Severity Score (TRISS). All injury severity scores were calculated using clinical findings, imaging results and surgical findings. A comprehensive data set was collated at the time of admission to the intensive care unit, encompassing patient age, gender, comorbidities, and the Charlson Comorbidity Index (CCI). The injury mechanism, blood sugar, haemoglobin and lactate levels, Horowitz index, hypotension and hypothermia were also recorded.The patients were categorised into two groups: survival and mortality
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survival | – | Other: Data of the patients were obtained from patient observation files and hospital information system database.consists of surviving patients |
| mortality | – | Other: Data of the patients were obtained from patient observation files and hospital information system database.consists of deceased patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The sample included patients with multiple trauma injuries who were admitted in the ICU between 01 January 2021 and 01 November 2023.
Key inclusion criteria (2 listed)
- Patients aged ≥18 years with patients with multiple trauma injuries
- Patients with a final outcome (survival or mortality) in our centre
Key exclusion criteria (3 listed)
- Patients with trauma to a single region (head, thorax, abdomen or extremities)
- Patients who were pregnant
- Length of intensive care unit stay ≤24 hours
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 |
|---|---|---|
| Data of the patients were obtained from patient observation files and hospital information system database.Data of the patients were obtained from patient observation files and hospital information system database. | Other | mortality, survival |
Primary outcome
The primary outcome of the study is mortality
Time frame: 01 January 2021 and 01 November 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma/Injuries, run by Melike Cengiz at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome of the study is mortality (time frame: 01 January 2021 and 01 November 2023). 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 22 Sep 2025.