- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06705959
Comparing NISS and ISS for Mortality Prediction in Trauma Patients (ISS/NISS/ER)
Can NISS or ISS Better Predict Mortality in Blunt Trauma Patients? A Prospective Study
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdulillah R. Khamees
- Phone Number: +9647838571013
- Email: allaabed987@ced.nahrainuniv.edu.iq
Study Locations
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Baghdad, Iraq
- Recruiting
- College of Medicine - Al-Nahrain University
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Principal Investigator:
- Abdul-Ilah R. Khamis
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Sub-Investigator:
- Mennatullah Fathi Ashour, Student
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Sub-Investigator:
- Athraa S. Ahmed, M.B.CH.B
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Sub-Investigator:
- Mohammed Kamal Zubaidi, M.B.CH.B
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Sub-Investigator:
- Amin A. Abdelaziz, Student
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Sub-Investigator:
- Mesan Hijazy
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Contact:
- Abdulillah R. Khamees
- Phone Number: +9647838571013
- Email: allaabed987@ced.nahrainuniv.edu.iq
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy Assessment of New Injury Severity Score (NISS)
Time Frame: the first 6 hours after ER admission
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Range: 0 to 75.
Higher values indicate worse outcomes, reflecting greater injury severity.
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the first 6 hours after ER admission
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Accuracy Assessment of Injury Severity Score (ISS)
Time Frame: the first 6 hours after ER admission
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Range: 0 to 75 Higher values indicate worse outcomes, reflecting greater injury severity.
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the first 6 hours after ER admission
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In hospital mortality
Time Frame: In-Hospital Phase (average of 7 days through discharge)
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Mortality (death) during hospitalization
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In-Hospital Phase (average of 7 days through discharge)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospitalization
Time Frame: Up to discharge, an average of 7 days
|
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.
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Up to discharge, an average of 7 days
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The requirement for admission to the intensive care unit (ICU)
Time Frame: Up to discharge, an average of 7 days
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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.
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Up to discharge, an average of 7 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Anees K Nile, Professor of general surgery, College Of Medicine - Nahrain University
Publications and helpful links
General Publications
- Hoke 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.
- 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.
- Pape 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.
- Whitaker 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.
- Jamulitrat 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.
- Deng 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.
- Tohira 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.
- Rio 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNCOMIRB20241122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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