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Not yet recruitingNCT07819279FOUR-TRAUMAUpdated Sep 14, 2026

FOUR Score-Modified Trauma Scores for Mortality Prediction

An observational study in Trauma Injury, Modified Trauma Scoring Systems and FOUR Score, sponsored by Al-Nahrain University. Not yet recruiting at 1 site in Iraq. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Al-Nahrain University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
16 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Trauma Injury
  • Modified Trauma Scoring Systems
  • FOUR Score

Keywords

  • Trauma
  • FOUR-TRAUMA
03

In context

Accidental Injuries

128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 170 across 59 observational studies indexed under Accidental Injuries.

Browse Accidental Injuries studies →

Lead sponsor

Al-Nahrain University is the lead sponsor of 26 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • Patients transferred from another hospital after initial resuscitation.
  • Patients who died before the required initial clinical assessment
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. In hospital mortality

    Mortality (death) during hospitalization

    Time frame: In-Hospital Phase (average of 10 days through discharge)

07

Study locations

1 site
08

References and documents

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 28452898 ↗
  • Javali 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 31086450 ↗
  • Champion 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 2657085 ↗
  • Sacco 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 16079430 ↗
  • Culley 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 25068943 ↗
  • Al-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 15289188 ↗
  • Alberdi 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 25241267 ↗
  • Rapsang 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 25015031 ↗
  • Omar 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 34829503 ↗
  • Beuran 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 22844826 ↗
  • Xiao 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07819279
Lead sponsor
Al-Nahrain University
Responsible party
Abdulillah R. Khamees (College Of Medicine - Nahrain University, Al-Nahrain University) — Principal investigator
First posted
Sep 14, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Abdulillah R. Khamees, MBBCH
Contact
abdulilah.r.khamis@gmail.com
07838571013

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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