Trauma InjuryFOUR-TRAUMANCT07819279
FOUR Score-Modified Trauma Scores for Mortality Prediction
An observational study of Trauma Injury and Modified Trauma Scoring Systems, run by Al-Nahrain University at 1 site in Iraq.
Trial summary
The goal of this multicenter prospective observational cohort study is to develop and validate FOUR Score-modified trauma scoring systems for mortality prediction in adult trauma patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma Injury, Modified Trauma Scoring Systems, FOUR Score
- How many people
- 2,000 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2026to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be recruited from adult trauma patients presenting to participating trauma centers across multiple hospitals. Participants will be prospectively enrolled during the study period, with standardized collection of clinical, physiological, and injury-related data at initial trauma assessment. The study will evaluate the performance of established trauma scoring systems and their corresponding FOUR Score-modified versions for mortality prediction.
Who may be able to join
- Patients with sufficient clinical data to calculate the fREMS score, including the FOUR Score and other required physiological variables.
- Patients with a documented mortality outcome .
Who cannot join
- Patients transferred from another hospital after initial resuscitation.
- Patients who died before the required initial clinical assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
College of Medicine - Al-Nahrain University
Baghdad, Please Select, 10011
Abdulillah R. Khamees, 07838571013, abdulilah.r.khamis@gmail.com
abdulilah.r.khamis@gmail.com
About this study
Official title: Development and Validation of FOUR Score-Modified Trauma Scoring Systems for Mortality Prediction in Trauma Patients: A Multicenter Prospective Observational Cohort Study
The goal of this multicenter prospective observational cohort study is to develop and validate FOUR Score-modified trauma scoring systems for mortality prediction in adult trauma patients. The main question it aims to answer is (1) do FOUR Score-modified versions of the Revised Trauma Score (RTS), Trauma and Injury Severity Score (TRISS), New Trauma Score (NTS), and Glasgow Coma Scale, Age, and Systolic Blood Pressure (GAP) Score improve mortality prediction compared with their corresponding original scores? Researchers will compare the original scoring systems with their corresponding FOUR Score-modified versions to assess differences in discrimination and overall predictive performance. Participants will undergo routine clinical assessment, including assessment of the Glasgow Coma Scale and Full Outline of UnResponsiveness Score, and relevant demographic, physiological, and injury-related data will be prospectively recorded; no experimental intervention will be administered.
Read the detailed description
Trauma is the leading cause of death worldwide, particularly in those younger than 35 years of age. Injuries and violence represent a major global public health, according to the World Health Organization (WHO), injuries and violence cause approximately 4.4 million deaths worldwide each year, accounting for nearly 8% of all deaths. Of these, about 3.16 million deaths are attributable to unintentional injuries and 1.25 million to violence-related injuries. Injuries and violence also contribute substantially to disability, with an estimated 10% of all years lived with disability attributed to these conditions.
Trauma severity scoring systems are important adjuncts to trauma care and are used to characterize the nature and extent of injury. They can support triage and assist in assessing and predicting patient outcomes, thereby helping to organize and improve trauma care systems. Trauma scoring systems can be divided into anatomical, physiological, and combined scores each with advantages and disadvantages. Anatomical scores describe the injuries recorded by clinical examination, imaging, surgery, or autopsy. While Physiologic Scores describe changes due to a trauma and translated by changes in vital signs and consciousness. The combination of anatomic scoring system and physiological scoring system is better than single scoring system for death prediction in patients with severe trauma in ICU, and it may be considered to be a new method for early identification of death risk in patients with severe trauma.
The Revised Trauma Score (RTS), a revision of the original Trauma Score developed by Champion et al., in 198, is a commonly used prehospital trauma triage tool. While there has been conceptual evolution of the core concept behind the RTS since its development, including the development of respiratory rate, pulse rate, and motor response (RPM) measure by Sacco et al., which may provide important mitigation of subjectivity of Glasgow Coma Scale (GCS) assessment, the RTS remains most prevalent in the literature. The RTS only requires three metrics to calculate: respiratory rate, systolic blood pressure, and GCS.
First introduced by Champion et al. in 1981, TRISS is a combination of the RTS and ISS with an age component. This system was to assess patients at the time of initial presentation to predict overall prognosis. Earlier studies had issues related to its applicability, but recent studies lend support to TRISS being a better scoring system when compared with others, such as ISS, NISS, and RTS. The past three decades have seen many international studies providing evidentiary support that it is, in fact, an accurate predictor of patient mortality.
More recent scoring systems, such as the Glasgow Coma Scale, Age, and Systolic Blood Pressure (GAP) score, have gained attention due to their simplicity and applicability in the field. The GAP score is especially relevant for traffic accident triage, as it can be quickly implemented at the scene, allowing for more efficient patient stratification and resource allocation. The New Trauma Score (NTS), which replaces the Respiratory Rate (RR) with arterial blood oxygen saturation percentage (SpO2), has shown improved performance over RTS in predicting mortality for trauma patients, including those from traffic accidents.
The Glasgow Coma Scale (GCS) provides an objective method for assessing the level of impaired consciousness in patients with acute medical conditions or trauma and is one of the most widely used neurological assessment scales. It evaluates three components of responsiveness: eye-opening, verbal, and motor responses, with each component reported separately to provide a detailed description of neurological status. The individual scores can also be combined into a total GCS score, providing a concise indication of overall severity. The GCS is widely used in trauma, emergency, and critical care settings and supports clinical assessment, triage, monitoring, and communication among healthcare professionals.
The Glasgow Coma Scale (GCS) has several limitations that can affect its reliability and clinical interpretation. The verbal component cannot be assessed reliably in patients who are intubated, pharmacologically sedated, or unable to speak, resulting in missing GCS values and limiting the use of the total score for prognostic models. The Glasgow Coma Scale (GCS) is limited in its ability to evaluate patients with concomitant head and spinal cord injury. Also, a comatose patient receives a GCS score of 3, which coincidentally matches the Glasgow Coma Scale (GCS) assigned to a deceased individual. Drug and alcohol intoxication can interfere with GCS assessment in trauma patients. DiGiorgio et al. found that intoxicated patients had greater changes in Glasgow Coma Scale (GCS) assigned scores than patients without detected substances, suggesting that intoxication may contribute to an initially depressed or variable Glasgow Coma Scale (GCS) assigned. The authors therefore recommended considering and addressing intoxicants when interpreting GCS scores to improve the accuracy of assessment and benchmarking. Painful stimuli used in the Best Eye and Best Motor Response assessments can complicate scoring, especially in polytrauma patients with spinal cord injuries.
The Full Outline of UnResponsiveness (FOUR) score is a coma scale consisting of four components: eye response, motor response, brainstem reflexes, and respiration, with each component assigned a maximum score of 4.
A study prospectively evaluated the Full Outline of UnResponsiveness (FOUR) score in 120 intensive care unit patients and compared it with the GCS among neuroscience nurses, neurology residents, and neurointensivists. The Full Outline of UnResponsiveness (FOUR) score showed excellent interrater reliability (weighted kappa = 0.82), with good to excellent agreement among physician raters. Agreement was similar to that of the Glasgow Coma Scale (GCS (weighted kappa = 0.82). The Full Outline of UnResponsiveness (FOUR) score further distinguished patients with the lowest Glasgow Coma Scale (GCS scores and provided greater neurological detail by assessing brainstem reflexes, breathing patterns, different stages of herniation, and recognizing locked-in syndrome. The probability of in-hospital mortality was higher among patients with the lowest total FOUR score compared with those with the lowest total Glasgow Coma Scale (GCS) score. In patients with traumatic brain injury, the Full Outline of UnResponsiveness (FOUR) score has been used as a predictor of outcome and all components of Full Outline of UnResponsiveness (FOUR) score can be assessed in intubated patients, because it does not include a verbal component. In a study of 51 Traumatic brain injury (TBI) patients, the area under the ROC curve for predicting in-hospital mortality was 0.93 for the Full Outline of UnResponsiveness (FOUR) score and 0.89 for the Glasgow Coma Scale (GCS). A study evaluated the Full Outline of UnResponsiveness (FOUR) in 101 neurosurgical patients with severely impaired consciousness (GCS <9), including patients with traumatic brain injury, intracranial hemorrhage, and malignant middle cerebral artery infarction. The AUC for mortality was 0.768 for the FOUR score and 0.699 for the GCS, indicating that Full Outline of UnResponsiveness (FOUR) score was more robust than the GCS in predicting mortality after 30 days in neurosurgical patients with severely impaired consciousness. For patients with acute brain injury, Full Outline of UnResponsiveness (FOUR) score demonstrated excellent inter-rater agreement, with a weighted kappa of 0.923, comparable to the Glasgow Coma Scale (GCS), and an area under curve (AUC) of 0.835 for predicting in-hospital mortality, compared with 0.772 for the Glasgow Coma Scale (GCS).
Despite the established utility of trauma scoring systems such as Revised Trauma Score (RTS), Trauma and Injury Severity Score (TRISS), New Trauma Score (NTS), and Glasgow Coma Scale, Age, and Systolic Blood Pressure Score (GAP) for mortality prediction, their incorporation of the Glasgow Coma Scale (GCS) may limit prognostic assessment in certain trauma patients, particularly when verbal responses cannot be reliably assessed. The Full Outline of UnResponsiveness Score (FOUR) Score provides additional neurological information through assessment of brainstem reflexes and respiratory pattern and can be evaluated in intubated patients without a verbal component. Although the Full Outline of UnResponsiveness Score (FOUR) Score has demonstrated promising predictive validity in patients with traumatic brain injury, its integration into established trauma scoring systems remains insufficiently evaluated. Therefore, this study aims to develop and validate FOUR Score-modified versions of the RTS, TRISS, NTS, and GAP scores; and compare their ability to predict mortality with their corresponding original scoring systems.
- Conditions
- Trauma Injury, Modified Trauma Scoring Systems, FOUR Score
- Keywords
- Trauma, FOUR-TRAUMA
- Medical subject headings
- Accidental Injuries, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality
Mortality (death) during hospitalization
Measured: In-Hospital Phase (average of 10 days through discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Nahrain University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulillah R. Khamees, Al-Nahrain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819279
- Sponsor's protocol ID
- UNCOMIRB20260909
- Acronym
- FOUR-TRAUMA
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Rein EAJ, Houwert RM, Gunning AC, Lichtveld RA, Leenen LPH, van Heijl M. Accuracy of prehospital triage protocols in selecting severely injured patients: A systematic review. J Trauma Acute Care Surg. 2017 Aug;83(2):328-339. doi: 10.1097/TA.0000000000001516.
PubMed 28452898Javali RH, Krishnamoorthy, Patil A, Srinivasarangan M, Suraj, Sriharsha. Comparison of Injury Severity Score, New Injury Severity Score, Revised Trauma Score and Trauma and Injury Severity Score for Mortality Prediction in Elderly Trauma Patients. Indian J Crit Care Med. 2019 Feb;23(2):73-77. doi: 10.5005/jp-journals-10071-23120.
PubMed 31086450Champion HR, Sacco WJ, Copes WS, Gann DS, Gennarelli TA, Flanagan ME. A revision of the Trauma Score. J Trauma. 1989 May;29(5):623-9. doi: 10.1097/00005373-198905000-00017.
PubMed 2657085Sacco WJ, Navin DM, Fiedler KE, Waddell RK 2nd, Long WB, Buckman RF Jr. Precise formulation and evidence-based application of resource-constrained triage. Acad Emerg Med. 2005 Aug;12(8):759-70. doi: 10.1197/j.aem.2005.04.003.
PubMed 16079430Culley JM, Svendsen E. A review of the literature on the validity of mass casualty triage systems with a focus on chemical exposures. Am J Disaster Med. 2014 Spring;9(2):137-50. doi: 10.5055/ajdm.2014.0150.
PubMed 25068943Al-Salamah MA, McDowell I, Stiell IG, Wells GA, Perry J, Al-Sultan M, Nesbitt L; OPALS Study Group. Initial emergency department trauma scores from the OPALS study: the case for the motor score in blunt trauma. Acad Emerg Med. 2004 Aug;11(8):834-42. doi: 10.1111/j.1553-2712.2004.tb00764.x.
PubMed 15289188Alberdi F, Garcia I, Atutxa L, Zabarte M; Trauma and Neurointensive Care Work Group of the SEMICYUC. Epidemiology of severe trauma. Med Intensiva. 2014 Dec;38(9):580-8. doi: 10.1016/j.medin.2014.06.012. Epub 2014 Sep 18. English, Spanish.
PubMed 25241267Rapsang AG, Shyam DC. Scoring systems of severity in patients with multiple trauma. Cir Esp. 2015 Apr;93(4):213-21. doi: 10.1016/j.ciresp.2013.12.021. Epub 2014 Jul 8. English, Spanish.
PubMed 25015031Omar A, Winkelmann M, Liodakis E, Clausen JD, Graulich T, Omar M, Krettek C, Macke C. Applicability of Anatomic and Physiologic Scoring Systems for the Prediction of Outcome in Polytraumatized Patients with Blunt Aortic Injuries. Diagnostics (Basel). 2021 Nov 21;11(11):2156. doi: 10.3390/diagnostics11112156.
PubMed 34829503Beuran M, Negoi I, Paun S, Runcanu A, Gaspar B, Vartic M. [Trauma scores: a review of the literature]. Chirurgia (Bucur). 2012 May-Jun;107(3):291-7. Romanian.
PubMed 22844826Xiao Y, Jin H, Mei H, Liu X, Chen T, Liu Z, Jiang D, Zhou J, Yan J, Liang H. [The predictive value of combination of anatomic scoring system and physiological scoring system in prediction of death in patients with severe trauma: a multicenter analysis of 614 cases]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015 Apr;27(4):291-4. doi: 10.3760/cma.j.issn.2095-4352.2015.04.013. Chinese.
PubMed 25891460
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of FOUR Score-Modified Trauma Scoring Systems for Mortality Prediction in Trauma Patients: A Multicenter Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07819279
- Acronym / sponsor ID
- FOUR-TRAUMA / UNCOMIRB20260909
- Conditions
- Trauma Injury, Modified Trauma Scoring Systems, FOUR Score
- Keywords
- Trauma, FOUR-TRAUMA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Al-Nahrain UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 14 Sep 2026 (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 goal of this multicenter prospective observational cohort study is to develop and validate FOUR Score-modified trauma scoring systems for mortality prediction in adult trauma patients. The main question it aims to answer is (1) do FOUR Score-modified versions of the Revised Trauma Score (RTS), Trauma and Injury Severity Score (TRISS), New Trauma Score (NTS), and Glasgow Coma Scale, Age, and Systolic Blood Pressure (GAP) Score improve mortality prediction compared with their corresponding original scores? Researchers will compare the original scoring systems with their corresponding FOUR Score-modified versions to assess differences in discrimination and overall predictive performance. Participants will undergo routine clinical assessment, including assessment of the Glasgow Coma Scale and Full Outline of UnResponsiveness Score, and relevant demographic, physiological, and injury-related data will be prospectively recorded; no experimental intervention will be administered.
Detailed description
Trauma is the leading cause of death worldwide, particularly in those younger than 35 years of age. Injuries and violence represent a major global public health, according to the World Health Organization (WHO), injuries and violence cause approximately 4.4 million deaths worldwide each year, accounting for nearly 8% of all deaths. Of these, about 3.16 million deaths are attributable to unintentional injuries and 1.25 million to violence-related injuries. Injuries and violence also contribute substantially to disability, with an estimated 10% of all years lived with disability attributed to these conditions.
Trauma severity scoring systems are important adjuncts to trauma care and are used to characterize the nature and extent of injury. They can support triage and assist in assessing and predicting patient outcomes, thereby helping to organize and improve trauma care systems. Trauma scoring systems can be divided into anatomical, physiological, and combined scores each with advantages and disadvantages. Anatomical scores describe the injuries recorded by clinical examination, imaging, surgery, or autopsy. While Physiologic Scores describe changes due to a trauma and translated by changes in vital signs and consciousness. The combination of anatomic scoring system and physiological scoring system is better than single scoring system for death prediction in patients with severe trauma in ICU, and it may be considered to be a new method for early identification of death risk in patients with severe trauma.
The Revised Trauma Score (RTS), a revision of the original Trauma Score developed by Champion et al., in 198, is a commonly used prehospital trauma triage tool. While there has been conceptual evolution of the core concept behind the RTS since its development, including the development of respiratory rate, pulse rate, and motor response (RPM) measure by Sacco et al., which may provide important mitigation of subjectivity of Glasgow Coma Scale (GCS) assessment, the RTS remains most prevalent in the literature. The RTS only requires three metrics to calculate: respiratory rate, systolic blood pressure, and GCS.
First introduced by Champion et al. in 1981, TRISS is a combination of the RTS and ISS with an age component. This system was to assess patients at the time of initial presentation to predict overall prognosis. Earlier studies had issues related to its applicability, but recent studies lend support to TRISS being a better scoring system when compared with others, such as ISS, NISS, and RTS. The past three decades have seen many international studies providing evidentiary support that it is, in fact, an accurate predictor of patient mortality.
More recent scoring systems, such as the Glasgow Coma Scale, Age, and Systolic Blood Pressure (GAP) score, have gained attention due to their simplicity and applicability in the field. The GAP score is especially relevant for traffic accident triage, as it can be quickly implemented at the scene, allowing for more efficient patient stratification and resource allocation. The New Trauma Score (NTS), which replaces the Respiratory Rate (RR) with arterial blood oxygen saturation percentage (SpO2), has shown improved performance over RTS in predicting mortality for trauma patients, including those from traffic accidents.
The Glasgow Coma Scale (GCS) provides an objective method for assessing the level of impaired consciousness in patients with acute medical conditions or trauma and is one of the most widely used neurological assessment scales. It evaluates three components of responsiveness: eye-opening, verbal, and motor responses, with each component reported separately to provide a detailed description of neurological status. The individual scores can also be combined into a total GCS score, providing a concise indication of overall severity. The GCS is widely used in trauma, emergency, and critical care settings and supports clinical assessment, triage, monitoring, and communication among healthcare professionals.
The Glasgow Coma Scale (GCS) has several limitations that can affect its reliability and clinical interpretation. The verbal component cannot be assessed reliably in patients who are intubated, pharmacologically sedated, or unable to speak, resulting in missing GCS values and limiting the use of the total score for prognostic models. The Glasgow Coma Scale (GCS) is limited in its ability to evaluate patients with concomitant head and spinal cord injury. Also, a comatose patient receives a GCS score of 3, which coincidentally matches the Glasgow Coma Scale (GCS) assigned to a deceased individual. Drug and alcohol intoxication can interfere with GCS assessment in trauma patients. DiGiorgio et al. found that intoxicated patients had greater changes in Glasgow Coma Scale (GCS) assigned scores than patients without detected substances, suggesting that intoxication may contribute to an initially depressed or variable Glasgow Coma Scale (GCS) assigned. The authors therefore recommended considering and addressing intoxicants when interpreting GCS scores to improve the accuracy of assessment and benchmarking. Painful stimuli used in the Best Eye and Best Motor Response assessments can complicate scoring, especially in polytrauma patients with spinal cord injuries.
The Full Outline of UnResponsiveness (FOUR) score is a coma scale consisting of four components: eye response, motor response, brainstem reflexes, and respiration, with each component assigned a maximum score of 4.
A study prospectively evaluated the Full Outline of UnResponsiveness (FOUR) score in 120 intensive care unit patients and compared it with the GCS among neuroscience nurses, neurology residents, and neurointensivists. The Full Outline of UnResponsiveness (FOUR) score showed excellent interrater reliability (weighted kappa = 0.82), with good to excellent agreement among physician raters. Agreement was similar to that of the Glasgow Coma Scale (GCS (weighted kappa = 0.82). The Full Outline of UnResponsiveness (FOUR) score further distinguished patients with the lowest Glasgow Coma Scale (GCS scores and provided greater neurological detail by assessing brainstem reflexes, breathing patterns, different stages of herniation, and recognizing locked-in syndrome. The probability of in-hospital mortality was higher among patients with the lowest total FOUR score compared with those with the lowest total Glasgow Coma Scale (GCS) score. In patients with traumatic brain injury, the Full Outline of UnResponsiveness (FOUR) score has been used as a predictor of outcome and all components of Full Outline of UnResponsiveness (FOUR) score can be assessed in intubated patients, because it does not include a verbal component. In a study of 51 Traumatic brain injury (TBI) patients, the area under the ROC curve for predicting in-hospital mortality was 0.93 for the Full Outline of UnResponsiveness (FOUR) score and 0.89 for the Glasgow Coma Scale (GCS). A study evaluated the Full Outline of UnResponsiveness (FOUR) in 101 neurosurgical patients with severely impaired consciousness (GCS <9), including patients with traumatic brain injury, intracranial hemorrhage, and malignant middle cerebral artery infarction. The AUC for mortality was 0.768 for the FOUR score and 0.699 for the GCS, indicating that Full Outline of UnResponsiveness (FOUR) score was more robust than the GCS in predicting mortality after 30 days in neurosurgical patients with severely impaired consciousness. For patients with acute brain injury, Full Outline of UnResponsiveness (FOUR) score demonstrated excellent inter-rater agreement, with a weighted kappa of 0.923, comparable to the Glasgow Coma Scale (GCS), and an area under curve (AUC) of 0.835 for predicting in-hospital mortality, compared with 0.772 for the Glasgow Coma Scale (GCS).
Despite the established utility of trauma scoring systems such as Revised Trauma Score (RTS), Trauma and Injury Severity Score (TRISS), New Trauma Score (NTS), and Glasgow Coma Scale, Age, and Systolic Blood Pressure Score (GAP) for mortality prediction, their incorporation of the Glasgow Coma Scale (GCS) may limit prognostic assessment in certain trauma patients, particularly when verbal responses cannot be reliably assessed. The Full Outline of UnResponsiveness Score (FOUR) Score provides additional neurological information through assessment of brainstem reflexes and respiratory pattern and can be evaluated in intubated patients without a verbal component. Although the Full Outline of UnResponsiveness Score (FOUR) Score has demonstrated promising predictive validity in patients with traumatic brain injury, its integration into established trauma scoring systems remains insufficiently evaluated. Therefore, this study aims to develop and validate FOUR Score-modified versions of the RTS, TRISS, NTS, and GAP scores; and compare their ability to predict mortality with their corresponding original scoring systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be recruited from adult trauma patients presenting to participating trauma centers across multiple hospitals. Participants will be prospectively enrolled during the study period, with standardized collection of clinical, physiological, and injury-related data at initial trauma assessment. The study will evaluate the performance of established trauma scoring systems and their corresponding FOUR Score-modified versions for mortality prediction.
Key inclusion criteria (2 listed)
- Patients with sufficient clinical data to calculate the fREMS score, including the FOUR Score and other required physiological variables.
- Patients with a documented mortality outcome .
Key exclusion criteria (2 listed)
- Patients transferred from another hospital after initial resuscitation.
- Patients who died before the required initial clinical assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In hospital mortality
Time frame: In-Hospital Phase (average of 10 days through discharge)
Mortality (death) during hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 28452898van Rein EAJ, Houwert RM, Gunning AC, Lichtveld RA, Leenen LPH, van Heijl M. Accuracy of prehospital triage protocols in selecting severely injured patients: A systematic review. J Trauma Acute Care Surg. 2017 Aug;83(2):328-339. doi: 10.1097/TA.0000000000001516.
- Background: PubMed 31086450Javali RH, Krishnamoorthy, Patil A, Srinivasarangan M, Suraj, Sriharsha. Comparison of Injury Severity Score, New Injury Severity Score, Revised Trauma Score and Trauma and Injury Severity Score for Mortality Prediction in Elderly Trauma Patients. Indian J Crit Care Med. 2019 Feb;23(2):73-77. doi: 10.5005/jp-journals-10071-23120.
- Background: PubMed 2657085Champion HR, Sacco WJ, Copes WS, Gann DS, Gennarelli TA, Flanagan ME. A revision of the Trauma Score. J Trauma. 1989 May;29(5):623-9. doi: 10.1097/00005373-198905000-00017.
- Background: PubMed 16079430Sacco WJ, Navin DM, Fiedler KE, Waddell RK 2nd, Long WB, Buckman RF Jr. Precise formulation and evidence-based application of resource-constrained triage. Acad Emerg Med. 2005 Aug;12(8):759-70. doi: 10.1197/j.aem.2005.04.003.
- Background: PubMed 25068943Culley JM, Svendsen E. A review of the literature on the validity of mass casualty triage systems with a focus on chemical exposures. Am J Disaster Med. 2014 Spring;9(2):137-50. doi: 10.5055/ajdm.2014.0150.
- Background: PubMed 15289188Al-Salamah MA, McDowell I, Stiell IG, Wells GA, Perry J, Al-Sultan M, Nesbitt L; OPALS Study Group. Initial emergency department trauma scores from the OPALS study: the case for the motor score in blunt trauma. Acad Emerg Med. 2004 Aug;11(8):834-42. doi: 10.1111/j.1553-2712.2004.tb00764.x.
- Background: PubMed 25241267Alberdi F, Garcia I, Atutxa L, Zabarte M; Trauma and Neurointensive Care Work Group of the SEMICYUC. Epidemiology of severe trauma. Med Intensiva. 2014 Dec;38(9):580-8. doi: 10.1016/j.medin.2014.06.012. Epub 2014 Sep 18. English, Spanish.
- Background: PubMed 25015031Rapsang AG, Shyam DC. Scoring systems of severity in patients with multiple trauma. Cir Esp. 2015 Apr;93(4):213-21. doi: 10.1016/j.ciresp.2013.12.021. Epub 2014 Jul 8. English, Spanish.
- Background: PubMed 34829503Omar A, Winkelmann M, Liodakis E, Clausen JD, Graulich T, Omar M, Krettek C, Macke C. Applicability of Anatomic and Physiologic Scoring Systems for the Prediction of Outcome in Polytraumatized Patients with Blunt Aortic Injuries. Diagnostics (Basel). 2021 Nov 21;11(11):2156. doi: 10.3390/diagnostics11112156.
- Background: PubMed 22844826Beuran M, Negoi I, Paun S, Runcanu A, Gaspar B, Vartic M. [Trauma scores: a review of the literature]. Chirurgia (Bucur). 2012 May-Jun;107(3):291-7. Romanian.
- Background: PubMed 25891460Xiao Y, Jin H, Mei H, Liu X, Chen T, Liu Z, Jiang D, Zhou J, Yan J, Liang H. [The predictive value of combination of anatomic scoring system and physiological scoring system in prediction of death in patients with severe trauma: a multicenter analysis of 614 cases]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015 Apr;27(4):291-4. doi: 10.3760/cma.j.issn.2095-4352.2015.04.013. Chinese.
- 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.
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 Trauma Injury and Modified Trauma Scoring Systems, run by Al-Nahrain University at 1 site in Iraq.
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 2 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: opening soon, as of the sponsor's last update on 14 Sep 2026. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdulillah R. Khamees, MBBCH (07838571013, abdulilah.r.khamis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital mortality (time frame: In-Hospital Phase (average of 10 days through discharge)). 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 NCT07819279, which also lists 11 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 14 Sep 2026.