TraumaISS/NISS/ERNCT06705959
Comparing NISS and ISS for Mortality Prediction in Trauma Patients
An observational study of Trauma, run by Al-Nahrain University at 1 site in Iraq.
Trial summary
The goal of this prospective cohort study is to compare the predictive utility of the New Injury Severity Score (NISS) and the Injury Severity Score (ISS) in determining mortality outcomes among trauma patients admitted to emergency rooms (ER) in Iraq. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- How many people
- 458 participants
- Where
- 1 siteIraq
- Study dates
- 10 Jun 2026to 15 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of trauma patients aged 18 years and older who are admitted to the emergency room (ER) at Al-Kadhimiya Teaching Hospital in Baghdad, Iraq. This group will include individuals with various types of injuries, such as those from road traffic accidents, falls, and assaults, excluding burns as the primary injury.
Who may be able to join
- Trauma patients admitted to the emergency room (ER).
- Patients with documented injury data are sufficient for calculating both the NISS and ISS.
- Patients admitted to the ER within 6 hours of injury.
- Patients providing informed consent (or consent obtained from a legal guardian in cases of incapacity).
Who cannot join
- Patients under 18 years of age.
- Trauma cases involving burns as the primary injury.
- Patients with incomplete medical records or insufficient data to calculate NISS and ISS.
- Patients with pre-existing terminal conditions (e.g., advanced cancer, end-stage organ failure) unrelated to the trauma.
- Patients who died on arrival or before NISS/ISS assessment could be performed.
- Cases involving pregnant patients, if the primary focus of injury and risk assessment is maternal-fetal outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the New Injury Severity Score (NISS) Outperform the Injury Severity Score (ISS) for Predicting Mortality Among Blunt Trauma Patients in a Conflict-Affected Setting?
The goal of this prospective cohort study is to compare the predictive utility of the New Injury Severity Score (NISS) and the Injury Severity Score (ISS) in determining mortality outcomes among trauma patients admitted to emergency rooms (ER) in Iraq.
The main questions it aims to answer are:
- Does the NISS provide a more accurate prediction of mortality than the ISS?
- Are there specific subgroups of trauma patients where one scoring system outperforms the other?
Participants will:
Be assessed using both the NISS and the ISS upon their ER admission. Have their clinical outcomes, including mortality, monitored throughout their hospital stay.
Read the detailed description
Trauma is a leading global cause of morbidity and mortality, particularly among individuals under 40 years of age, accounting for approximately 5 million deaths annually. To address the challenges of assessing trauma severity, tools like the Injury Severity Score (ISS) and the New Injury Severity Score (NISS) have been developed to predict patient outcomes, including mortality. The ISS, introduced in 1974, is based on the Abbreviated Injury Scale and evaluates the three most severely injured body regions. However, it has limitations, including its inability to account for multiple injuries in the same body region. To overcome these, the NISS was introduced in 1997, summing the squares of the three most severe injuries, irrespective of location, potentially offering improved predictive accuracy in certain trauma populations.
The predictive accuracy of ISS and NISS has been extensively studied, with mixed findings. Meta-analyses and cohort studies suggest both tools are effective, with NISS often demonstrating slightly superior sensitivity and area under the curve (AUC) for mortality prediction. For instance, one analysis reported an AUC of 0.9095 for NISS versus 0.9009 for ISS in predicting mortality. While both tools are considered reliable, NISS's ability to account for multiple severe injuries within the same region makes it particularly advantageous in cases of polytrauma.
Despite these advances, significant heterogeneity exists among studies, largely due to differences in trauma mechanisms, patient populations, and study methodologies. For instance, blunt versus penetrating trauma and age-related factors can influence the tools' performance. Additionally, the lack of standardized reporting and quality assurance in scoring further complicates comparisons, highlighting a need for more uniform research protocols.
In Iraq, where trauma from road traffic accidents and violence is prevalent, evaluating the predictive utility of ISS and NISS is particularly important. Despite the global use of these tools, limited data exists on their effectiveness in Middle Eastern populations, where differences in healthcare infrastructure and injury patterns may affect performance. This study aims to address this gap by comparing the mortality predictive abilities of ISS and NISS in an Iraqi trauma population. Understanding their relative effectiveness in this context could inform better resource allocation, improve trauma care, and guide future research tailored to local needs.
- Conditions
- Trauma
- Keywords
- NISS, ISS, Trauma, ER
- Medical subject headings
- 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 7 days through discharge)
Accuracy Assessment of New Injury Severity Score (NISS)
Range: 0 to 75. Higher values indicate worse outcomes, reflecting greater injury severity.
Measured: the first 6 hours after ER admission
Accuracy Assessment of Injury Severity Score (ISS)
Range: 0 to 75 Higher values indicate worse outcomes, reflecting greater injury severity.
Measured: the first 6 hours after ER admission
Secondary outcomes (2)
Length of Hospitalization
The total duration of a patient's stay in the hospital, measured from the date of admission to the date of discharge. This includes all days spent in general wards, intensive care units (ICU), and other hospital departments as part of their treatment course.
Measured: Up to discharge, an average of 7 days
The requirement for admission to the intensive care unit (ICU)
The requirement for admission to the intensive care unit (ICU) is determined by the presence of severe clinical deterioration, significant complications, or the need for advanced monitoring and life-support measures.
Measured: Up to discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start10 Jun 2026
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies 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
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Nahrain University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulillah R. Khamees, Al-Nahrain University
- Investigators
- Anees K Nile, Professor of general surgery, Study director, College Of Medicine - Nahrain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705959
- Sponsor's protocol ID
- UNCOMIRB20241122
- Acronym
- ISS/NISS/ER
- Status last verified
- Sep 2026
- First submitted
- 23 Nov 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Palmer CS, Gabbe BJ, Cameron PA. Defining major trauma using the 2008 Abbreviated Injury Scale. Injury. 2016 Jan;47(1):109-15. doi: 10.1016/j.injury.2015.07.003. Epub 2015 Jul 10.
PubMed 26283084Pape HC, Halvachizadeh S, Leenen L, Velmahos GD, Buckley R, Giannoudis PV. Timing of major fracture care in polytrauma patients - An update on principles, parameters and strategies for 2020. Injury. 2019 Oct;50(10):1656-1670. doi: 10.1016/j.injury.2019.09.021. Epub 2019 Sep 13.
PubMed 31558277Whitaker IY, Gennari TD, Whitaker AL. The difference between ISS and NISS in a series of trauma patients in Brazil. Annu Proc Assoc Adv Automot Med. 2003;47:301-9.
PubMed 12941232Hoke MH, Usul E, Ozkan S. Comparison of Trauma Severity Scores (ISS, NISS, RTS, BIG Score, and TRISS) in Multiple Trauma Patients. J Trauma Nurs. 2021 Apr-Jun 01;28(2):100-106. doi: 10.1097/JTN.0000000000000567.
PubMed 33667204Jamulitrat S, Sangkerd P, Thongpiyapoom S, Na Narong M. A comparison of mortality predictive abilities between NISS and ISS in trauma patients. J Med Assoc Thai. 2001 Oct;84(10):1416-21.
PubMed 11804251Deng Q, Tang B, Xue C, Liu Y, Liu X, Lv Y, Zhang L. Comparison of the Ability to Predict Mortality between the Injury Severity Score and the New Injury Severity Score: A Meta-Analysis. Int J Environ Res Public Health. 2016 Aug 16;13(8):825. doi: 10.3390/ijerph13080825.
PubMed 27537902Tohira H, Jacobs I, Mountain D, Gibson N, Yeo A. Systematic review of predictive performance of injury severity scoring tools. Scand J Trauma Resusc Emerg Med. 2012 Sep 10;20:63. doi: 10.1186/1757-7241-20-63.
PubMed 22964071Rio TGGND, Nogueira LS, Lima FR, Cassiano C, Garcia DFV. Performance of severity indices for admission and mortality of trauma patients in the intensive care unit: a retrospective cohort study. Eur J Med Res. 2023 Dec 4;28(1):559. doi: 10.1186/s40001-023-01532-6.
PubMed 38049903
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the New Injury Severity Score (NISS) Outperform the Injury Severity Score (ISS) for Predicting Mortality Among Blunt Trauma Patients in a Conflict-Affected Setting?
- ClinicalTrials.gov ID
- NCT06705959
- Acronym / sponsor ID
- ISS/NISS/ER / UNCOMIRB20241122
- Conditions
- Trauma
- Keywords
- NISS, ISS, Trauma, ER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Al-Nahrain UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 26 Nov 2024 (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 prospective cohort study is to compare the predictive utility of the New Injury Severity Score (NISS) and the Injury Severity Score (ISS) in determining mortality outcomes among trauma patients admitted to emergency rooms (ER) in Iraq.
The main questions it aims to answer are:
- Does the NISS provide a more accurate prediction of mortality than the ISS?
- Are there specific subgroups of trauma patients where one scoring system outperforms the other?
Participants will:
Be assessed using both the NISS and the ISS upon their ER admission. Have their clinical outcomes, including mortality, monitored throughout their hospital stay.
Detailed description
Trauma is a leading global cause of morbidity and mortality, particularly among individuals under 40 years of age, accounting for approximately 5 million deaths annually. To address the challenges of assessing trauma severity, tools like the Injury Severity Score (ISS) and the New Injury Severity Score (NISS) have been developed to predict patient outcomes, including mortality. The ISS, introduced in 1974, is based on the Abbreviated Injury Scale and evaluates the three most severely injured body regions. However, it has limitations, including its inability to account for multiple injuries in the same body region. To overcome these, the NISS was introduced in 1997, summing the squares of the three most severe injuries, irrespective of location, potentially offering improved predictive accuracy in certain trauma populations.
The predictive accuracy of ISS and NISS has been extensively studied, with mixed findings. Meta-analyses and cohort studies suggest both tools are effective, with NISS often demonstrating slightly superior sensitivity and area under the curve (AUC) for mortality prediction. For instance, one analysis reported an AUC of 0.9095 for NISS versus 0.9009 for ISS in predicting mortality. While both tools are considered reliable, NISS's ability to account for multiple severe injuries within the same region makes it particularly advantageous in cases of polytrauma.
Despite these advances, significant heterogeneity exists among studies, largely due to differences in trauma mechanisms, patient populations, and study methodologies. For instance, blunt versus penetrating trauma and age-related factors can influence the tools' performance. Additionally, the lack of standardized reporting and quality assurance in scoring further complicates comparisons, highlighting a need for more uniform research protocols.
In Iraq, where trauma from road traffic accidents and violence is prevalent, evaluating the predictive utility of ISS and NISS is particularly important. Despite the global use of these tools, limited data exists on their effectiveness in Middle Eastern populations, where differences in healthcare infrastructure and injury patterns may affect performance. This study aims to address this gap by comparing the mortality predictive abilities of ISS and NISS in an Iraqi trauma population. Understanding their relative effectiveness in this context could inform better resource allocation, improve trauma care, and guide future research tailored to local needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of trauma patients aged 18 years and older who are admitted to the emergency room (ER) at Al-Kadhimiya Teaching Hospital in Baghdad, Iraq. This group will include individuals with various types of injuries, such as those from road traffic accidents, falls, and assaults, excluding burns as the primary injury.
Key inclusion criteria (4 listed)
- Trauma patients admitted to the emergency room (ER).
- Patients with documented injury data are sufficient for calculating both the NISS and ISS.
- Patients admitted to the ER within 6 hours of injury.
- Patients providing informed consent (or consent obtained from a legal guardian in cases of incapacity).
Key exclusion criteria (6 listed)
- Patients under 18 years of age.
- Trauma cases involving burns as the primary injury.
- Patients with incomplete medical records or insufficient data to calculate NISS and ISS.
- Patients with pre-existing terminal conditions (e.g., advanced cancer, end-stage organ failure) unrelated to the trauma.
- Patients who died on arrival or before NISS/ISS assessment could be performed.
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 7 days through discharge)
Mortality (death) during hospitalization
Accuracy Assessment of New Injury Severity Score (NISS)
Time frame: the first 6 hours after ER admission
Range: 0 to 75. Higher values indicate worse outcomes, reflecting greater injury severity.
Accuracy Assessment of Injury Severity Score (ISS)
Time frame: the first 6 hours after ER admission
Range: 0 to 75 Higher values indicate worse outcomes, reflecting greater injury severity.
2 secondary outcomes
Length of Hospitalization
Time frame: Up to discharge, an average of 7 days
The requirement for admission to the intensive care unit (ICU)
Time frame: Up to discharge, an average of 7 days
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 10 Sep 2026.
- Results publication: PubMed 26283084Palmer CS, Gabbe BJ, Cameron PA. Defining major trauma using the 2008 Abbreviated Injury Scale. Injury. 2016 Jan;47(1):109-15. doi: 10.1016/j.injury.2015.07.003. Epub 2015 Jul 10.
- Results publication: PubMed 31558277Pape HC, Halvachizadeh S, Leenen L, Velmahos GD, Buckley R, Giannoudis PV. Timing of major fracture care in polytrauma patients - An update on principles, parameters and strategies for 2020. Injury. 2019 Oct;50(10):1656-1670. doi: 10.1016/j.injury.2019.09.021. Epub 2019 Sep 13.
- Results publication: PubMed 12941232Whitaker IY, Gennari TD, Whitaker AL. The difference between ISS and NISS in a series of trauma patients in Brazil. Annu Proc Assoc Adv Automot Med. 2003;47:301-9.
- Results publication: PubMed 33667204Hoke MH, Usul E, Ozkan S. Comparison of Trauma Severity Scores (ISS, NISS, RTS, BIG Score, and TRISS) in Multiple Trauma Patients. J Trauma Nurs. 2021 Apr-Jun 01;28(2):100-106. doi: 10.1097/JTN.0000000000000567.
- Results publication: PubMed 11804251Jamulitrat S, Sangkerd P, Thongpiyapoom S, Na Narong M. A comparison of mortality predictive abilities between NISS and ISS in trauma patients. J Med Assoc Thai. 2001 Oct;84(10):1416-21.
- Results publication: PubMed 27537902Deng Q, Tang B, Xue C, Liu Y, Liu X, Lv Y, Zhang L. Comparison of the Ability to Predict Mortality between the Injury Severity Score and the New Injury Severity Score: A Meta-Analysis. Int J Environ Res Public Health. 2016 Aug 16;13(8):825. doi: 10.3390/ijerph13080825.
- Results publication: PubMed 22964071Tohira H, Jacobs I, Mountain D, Gibson N, Yeo A. Systematic review of predictive performance of injury severity scoring tools. Scand J Trauma Resusc Emerg Med. 2012 Sep 10;20:63. doi: 10.1186/1757-7241-20-63.
- Results publication: PubMed 38049903Rio TGGND, Nogueira LS, Lima FR, Cassiano C, Garcia DFV. Performance of severity indices for admission and mortality of trauma patients in the intensive care unit: a retrospective cohort study. Eur J Med Res. 2023 Dec 4;28(1):559. doi: 10.1186/s40001-023-01532-6.
- 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. This study is not recruiting at the moment.
Anees K Nile, Professor of general surgery study director
College Of Medicine - Nahrain 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 Trauma, 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 4 inclusion and 6 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 10 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?
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?
In hospital mortality (time frame: In-Hospital Phase (average of 7 days through discharge)). The study lists 3 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 NCT06705959, which also lists 8 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 10 Sep 2026.