Comparing NISS and ISS for Mortality Prediction in Trauma Patients (ISS/NISS/ER)

April 24, 2025 updated by: Abdul-Ilah R. Khamis, Al-Nahrain University

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

Recruiting

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

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Baghdad, Iraq
        • Recruiting
        • College of Medicine - Al-Nahrain University
        • Principal Investigator:
          • Abdul-Ilah R. Khamis
        • Sub-Investigator:
          • Mennatullah Fathi Ashour, Student
        • Sub-Investigator:
          • Athraa S. Ahmed, M.B.CH.B
        • Sub-Investigator:
          • Mohammed Kamal Zubaidi, M.B.CH.B
        • Sub-Investigator:
          • Amin A. Abdelaziz, Student
        • Sub-Investigator:
          • Mesan Hijazy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Range: 0 to 75. Higher values indicate worse outcomes, reflecting greater injury severity.
the first 6 hours after ER admission
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.
the first 6 hours after ER admission
In hospital mortality
Time Frame: In-Hospital Phase (average of 7 days through discharge)
Mortality (death) during hospitalization
In-Hospital Phase (average of 7 days through discharge)

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.
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
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.
Up to discharge, an average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Anees K Nile, Professor of general surgery, College Of Medicine - Nahrain University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 28, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

November 23, 2024

First Submitted That Met QC Criteria

November 23, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNCOMIRB20241122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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