Thorax TraumasNCT06930222
The Investigation of Predicting Mortality and Morbidity in Patients Admitted to Intensive Care Unit With Thoracic Trauma Using Selected Biomarkers and Parameters
An observational study of Thorax Traumas, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
This prospective study aimed to predict morbidity and mortality after thoracic trauma in intensive care unit evaluated clinical and biochemical data of 50 intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thorax Traumas
- What is being tested?
- blood sampling
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Apr 2024
- How long will I take part?
- 6 Weeks
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thoracic trauma admitted to icu
Who may be able to join
- Patients with thoracic trauma between the ages of 18-85
- Patients who have been monitored in intensive care for at least 1 week
Who cannot join
- Being outside the age range of 18-85
- Pregnant patients
- Patients whose intensive care follow-up lasted less than 1 week
- Patients who do not want to be included in the study
- Patients with a lung malignancy diagnosis before admission
Trial locations and contacts
1 site in 1 country.
About this study
This prospective study aimed to predict morbidity and mortality after thoracic trauma in intensive care unit evaluated clinical and biochemical data of 50 intensive care unit patients. The research examined demographic factors such as gender, age, and smoking status, trauma scoring systems like ISS and RTS as well as biomarkers such as Surfactant-d and oxygenation parameters including the ROX index, PaO₂/FiO₂ ratio and FiO₂.
- Conditions
- Thorax Traumas
- Being tested
- blood sampling
- Keywords
- thorax trauma, ROX index, Surfactant-d
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic test
blood samples obtained for 3 different days, limited to 5cc
| Study group | Role | What they receive |
|---|---|---|
| thorax trauma patients | thorax trauma patients admitted to icu Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Prediction Using ROX Index in Thoracic Trauma Patients
To evaluate the predictive ability of the ROX index (unit: cmH₂O/L/s) for mortality in thoracic trauma patients. ROX index values were recorded at 1st, 3rd, and 7th days of hospitalization using standard clinical monitoring and ventilatory support parameters. Trends were analyzed in relation to survival outcomes.
Measured: Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.
Mortality Prediction Using SP-D Levels in Thoracic Trauma Patients
To assess the prognostic value of Surfactant Protein D (SP-D) levels (unit: ng/mL) for mortality prediction in thoracic trauma patients. SP-D levels were measured using an ELISA assay (Elabscience® Human Pulmonary Surfactant-associated Protein-D ELISA Kit) at 1st, 3rd, and 7th days to evaluate trends and correlations with survival outcomes.
Measured: Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.
Secondary outcomes (6)
Predictive Value of APACHE II Score in Mortality
To analyze the effectiveness of the APACHE II score (range: 0-71; higher scores indicate worse outcomes) in predicting mortality in thoracic trauma patients. APACHE II scores were calculated based on clinical and laboratory parameters, including vital signs, blood gas values, and organ dysfunction markers at 1st, 3rd, and 7th days.
Measured: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Predictive Value of SOFA Score in Mortality
To evaluate the prognostic accuracy of the Sequential Organ Failure Assessment (SOFA) score (range: 0-24; higher scores indicate worse outcomes) in thoracic trauma patients. SOFA scores were determined based on respiratory, cardiovascular, hepatic, coagulation, renal, and neurological functions at 1st, 3rd, and 7th days.
Measured: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Predictive Value of TRISS Score in Mortality
To examine the relationship between Trauma and Injury Severity Score (TRISS) (range: 0-100%; higher scores indicate better survival probability) and survival outcomes in thoracic trauma patients. TRISS scores were calculated using physiological and anatomical injury severity data at 1st, 3rd, and 7th days.
Measured: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Predictive Value of RTS Score in Mortality
To assess the relationship between Revised Trauma Score (RTS) (range: 0-7.84; higher scores indicate better prognosis) and mortality risk in thoracic trauma patients. RTS scores were calculated using Glasgow Coma Scale, systolic blood pressure, and respiratory rate values at 1st, 3rd, and 7th days.
Measured: Measurements taken on day 1, day 3, and day 7 of hospitalization.
CRP Levels and Mortality Prediction
To evaluate the association between C-reactive protein (CRP) levels (unit: mg/L) and mortality in thoracic trauma patients.
Measured: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Procalcitonin Levels and Mortality Prediction
To analyze the prognostic value of procalcitonin (unit: ng/mL) levels in mortality prediction among thoracic trauma patients.
Measured: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start15 Apr 2023
- Primary completion15 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thorax TraumasStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Sencer CELİK, Suleyman Demirel University
- Investigators
- pınar karabacak, Study director, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930222
- Sponsor's protocol ID
- SENCER-CELIK-001
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Determann RM, Royakkers AA, Haitsma JJ, Zhang H, Slutsky AS, Ranieri VM, Schultz MJ. Plasma levels of surfactant protein D and KL-6 for evaluation of lung injury in critically ill mechanically ventilated patients. BMC Pulm Med. 2010 Feb 16;10:6. doi: 10.1186/1471-2466-10-6.
PubMed 20158912Baker JE, Millar DA, Heh V, Goodman MD, Pritts TA, Janowak CF. Does chest wall Organ Injury Scale (OIS) or Abbreviated Injury Scale (AIS) predict outcomes? An analysis of 16,000 consecutive rib fractures. Surgery. 2020 Jul;168(1):198-204. doi: 10.1016/j.surg.2020.04.032. Epub 2020 May 13.
PubMed 32507628Lundin A, Akram SK, Berg L, Goransson KE, Enocson A. Thoracic injuries in trauma patients: epidemiology and its influence on mortality. Scand J Trauma Resusc Emerg Med. 2022 Dec 12;30(1):69. doi: 10.1186/s13049-022-01058-6.
PubMed 36503613
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Predicting Mortality and Morbidity in Patients Admitted to Intensive Care Unit With Thoracic Trauma Using Selected Biomarkers and Parameters
- ClinicalTrials.gov ID
- NCT06930222
- Acronym / sponsor ID
- SENCER-CELIK-001
- Conditions
- Thorax Traumas
- Keywords
- thorax trauma, ROX index, Surfactant-d
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 16 Apr 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.
This prospective study aimed to predict morbidity and mortality after thoracic trauma in intensive care unit evaluated clinical and biochemical data of 50 intensive care unit patients. The research examined demographic factors such as gender, age, and smoking status, trauma scoring systems like ISS and RTS as well as biomarkers such as Surfactant-d and oxygenation parameters including the ROX index, PaO₂/FiO₂ ratio and FiO₂.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thorax trauma patients | – | Diagnostic Test: blood samplingthorax trauma patients admitted to icu |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thoracic trauma admitted to icu
Key inclusion criteria (2 listed)
- Patients with thoracic trauma between the ages of 18-85
- Patients who have been monitored in intensive care for at least 1 week
Key exclusion criteria (5 listed)
- Being outside the age range of 18-85
- Pregnant patients
- Patients whose intensive care follow-up lasted less than 1 week
- Patients who do not want to be included in the study
- Patients with a lung malignancy diagnosis before admission
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 |
|---|---|---|
| blood samplingblood samples obtained for 3 different days, limited to 5cc | Diagnostic test | thorax trauma patients |
Primary outcome
Mortality Prediction Using ROX Index in Thoracic Trauma Patients
Time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.
To evaluate the predictive ability of the ROX index (unit: cmH₂O/L/s) for mortality in thoracic trauma patients. ROX index values were recorded at 1st, 3rd, and 7th days of hospitalization using standard clinical monitoring and ventilatory support parameters. Trends were analyzed in relation to survival outcomes.
Mortality Prediction Using SP-D Levels in Thoracic Trauma Patients
Time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.
To assess the prognostic value of Surfactant Protein D (SP-D) levels (unit: ng/mL) for mortality prediction in thoracic trauma patients. SP-D levels were measured using an ELISA assay (Elabscience® Human Pulmonary Surfactant-associated Protein-D ELISA Kit) at 1st, 3rd, and 7th days to evaluate trends and correlations with survival outcomes.
6 secondary outcomes
Predictive Value of APACHE II Score in Mortality
Time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Predictive Value of SOFA Score in Mortality
Time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Predictive Value of TRISS Score in Mortality
Time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Predictive Value of RTS Score in Mortality
Time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
CRP Levels and Mortality Prediction
Time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
Procalcitonin Levels and Mortality Prediction
Time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
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 16 Apr 2025.
- Background: PubMed 20158912Determann RM, Royakkers AA, Haitsma JJ, Zhang H, Slutsky AS, Ranieri VM, Schultz MJ. Plasma levels of surfactant protein D and KL-6 for evaluation of lung injury in critically ill mechanically ventilated patients. BMC Pulm Med. 2010 Feb 16;10:6. doi: 10.1186/1471-2466-10-6.
- Background: PubMed 32507628Baker JE, Millar DA, Heh V, Goodman MD, Pritts TA, Janowak CF. Does chest wall Organ Injury Scale (OIS) or Abbreviated Injury Scale (AIS) predict outcomes? An analysis of 16,000 consecutive rib fractures. Surgery. 2020 Jul;168(1):198-204. doi: 10.1016/j.surg.2020.04.032. Epub 2020 May 13.
- Background: PubMed 36503613Lundin A, Akram SK, Berg L, Goransson KE, Enocson A. Thoracic injuries in trauma patients: epidemiology and its influence on mortality. Scand J Trauma Resusc Emerg Med. 2022 Dec 12;30(1):69. doi: 10.1186/s13049-022-01058-6.
- Individual participant dataSharing planned: Undecided
Related trials for Thorax Traumas
Not yet recruitingObservational study
Medical,Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma Patient
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
RecruitingObservational study
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
Small Cell Lung Cancer ( SCLC ), Brain Injury
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
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.
pınar karabacak study director
Suleyman Demirel University
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 Thorax Traumas, run by Suleyman Demirel University 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 5 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 16 Apr 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?
Mortality Prediction Using ROX Index in Thoracic Trauma Patients (time frame: Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06930222, which also lists 3 linked publications.
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 16 Apr 2025.