TBIfREMSNCT07816016
fREMS for Mortality Prediction in TBI
An observational study of TBI and TBI Traumatic Brain Injury, run by Al-Nahrain University at 1 site in Iraq.
Trial summary
This prospective observational study aims to develop and internally validate a new clinical score, the FOUR-Rapid Emergency Medicine Score (fREMS), for predicting in-hospital mortality in patients with traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- TBI, TBI Traumatic Brain Injury
- How many people
- 2,000 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2026to 1 Oct 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 consisted of adult patients (≥16 years) with acute traumatic brain injury (TBI).
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 - Nahrain University
Baghdad, Baghdad Governorate, 10011
Abdulillah R. Khamees, MBBCH, 07838571013 ext. +964, abdulilah.r.khamis@gmail.com
abdulilah.r.khamis@gmail.com
About this study
Official title: Development and Validation of a Novel FOUR-Rapid Emergency Medicine Score (fREMS) for Mortality Prediction in Traumatic Brain Injury Patients
This prospective observational study aims to develop and internally validate a new clinical score, the FOUR-Rapid Emergency Medicine Score (fREMS), for predicting in-hospital mortality in patients with traumatic brain injury (TBI). The study will assess whether combining the Full Outline of UnResponsiveness (FOUR) score with physiological and clinical parameters from the Rapid Emergency Medicine Score (REMS) can improve early mortality prediction. The main question it aims to answer is:
Can the fREMS score accurately predict the risk of in-hospital mortality in patients with traumatic brain injury?
Data on demographic characteristics, vital signs, neurological assessment, and other relevant clinical variables will be collected from eligible patients with TBI and used to develop and validate the fREMS score.
Read the detailed description
Background 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 issue. 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. The combination of the anatomic scoring system and the physiological scoring system is better than a single scoring system for death prediction in patients with severe trauma in the ICU, and it may be considered to be a new method for early identification of death risk in patients with severe trauma.
The Rapid Emergency Medicine Score (REMS) is a physiological scoring system developed from the Acute Physiology and Chronic Health Evaluation II (APACHE II), which is considered a more rapid and less invasive version and is used for rapid risk stratification and prediction of mortality. It includes several parameters: age, mean arterial pressure, respiratory rate, pulse rate, peripheral oxygen saturation, and Glasgow Coma Scale (GCS). The modified REMS (mREMS) was subsequently developed specifically for trauma by substituting systolic blood pressure for mean arterial pressure, reducing the weighting of age, and increasing the weighting of GCS; in a large validation cohort, mREMS showed an AUROC of 0.967 for predicting in-hospital mortality.
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 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 the 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).
Despite the established prognostic value of REMS and the FOUR score in critically ill and trauma patients, their combined use for mortality prediction in patients with traumatic brain injury (TBI) remains insufficiently explored. The incorporation of GCS within REMS may limit its applicability in severe TBI, particularly when the verbal component cannot be reliably assessed in intubated or sedated patients. The FOUR score may overcome this limitation by providing a more comprehensive neurological assessment without requiring a verbal response. Therefore, integrating the FOUR score with the physiological parameters of REMS may provide a simple and clinically applicable tool for early mortality risk stratification in TBI. Accordingly, this study aimed to develop and internally validate the FOUR-Rapid Emergency Medicine Score (fREMS) for predicting in-hospital mortality among patients with TBI.
- Conditions
- TBI, TBI Traumatic Brain Injury
- Keywords
- TBI, fREMS, Trauma score
- Medical subject headings
- Brain Injuries, Traumatic
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 15 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 posted11 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TBIStudies 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
- NCT07816016
- Sponsor's protocol ID
- UNCOMIRB20260905
- Acronym
- fREMS
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 25891460Beuran 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 22844826Omar 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 34829503Rapsang 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 25015031Alberdi 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Novel FOUR-Rapid Emergency Medicine Score (fREMS) for Mortality Prediction in Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT07816016
- Acronym / sponsor ID
- fREMS / UNCOMIRB20260905
- Conditions
- TBI, TBI Traumatic Brain Injury
- Keywords
- TBI, fREMS, Trauma score
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Al-Nahrain UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 11 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.
This prospective observational study aims to develop and internally validate a new clinical score, the FOUR-Rapid Emergency Medicine Score (fREMS), for predicting in-hospital mortality in patients with traumatic brain injury (TBI). The study will assess whether combining the Full Outline of UnResponsiveness (FOUR) score with physiological and clinical parameters from the Rapid Emergency Medicine Score (REMS) can improve early mortality prediction. The main question it aims to answer is:
Can the fREMS score accurately predict the risk of in-hospital mortality in patients with traumatic brain injury?
Data on demographic characteristics, vital signs, neurological assessment, and other relevant clinical variables will be collected from eligible patients with TBI and used to develop and validate the fREMS score.
Detailed description
Background 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 issue. 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. The combination of the anatomic scoring system and the physiological scoring system is better than a single scoring system for death prediction in patients with severe trauma in the ICU, and it may be considered to be a new method for early identification of death risk in patients with severe trauma.
The Rapid Emergency Medicine Score (REMS) is a physiological scoring system developed from the Acute Physiology and Chronic Health Evaluation II (APACHE II), which is considered a more rapid and less invasive version and is used for rapid risk stratification and prediction of mortality. It includes several parameters: age, mean arterial pressure, respiratory rate, pulse rate, peripheral oxygen saturation, and Glasgow Coma Scale (GCS). The modified REMS (mREMS) was subsequently developed specifically for trauma by substituting systolic blood pressure for mean arterial pressure, reducing the weighting of age, and increasing the weighting of GCS; in a large validation cohort, mREMS showed an AUROC of 0.967 for predicting in-hospital mortality.
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 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 the 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).
Despite the established prognostic value of REMS and the FOUR score in critically ill and trauma patients, their combined use for mortality prediction in patients with traumatic brain injury (TBI) remains insufficiently explored. The incorporation of GCS within REMS may limit its applicability in severe TBI, particularly when the verbal component cannot be reliably assessed in intubated or sedated patients. The FOUR score may overcome this limitation by providing a more comprehensive neurological assessment without requiring a verbal response. Therefore, integrating the FOUR score with the physiological parameters of REMS may provide a simple and clinically applicable tool for early mortality risk stratification in TBI. Accordingly, this study aimed to develop and internally validate the FOUR-Rapid Emergency Medicine Score (fREMS) for predicting in-hospital mortality among patients with TBI.
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 consisted of adult patients (≥16 years) with acute traumatic brain injury (TBI).
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 15 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 15 Sep 2026.
- 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.
- 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 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 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 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.
- 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 TBI and TBI Traumatic Brain Injury, 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 15 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 15 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 NCT07816016, which also lists 5 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 15 Sep 2026.