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NCT Number: NCT06705959

Comparing NISS and ISS for Mortality Prediction in Trauma Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

College of Medicine - Al-Nahrain University

Baghdad, Iraq

Location status: Recruiting

Location contact

Abdul-Ilah R. Khamis

PRINCIPAL_INVESTIGATOR

Abdulillah R. Khamees

CONTACT

[email protected]

+9647838571013

Amin A. Abdelaziz, Student

SUB_INVESTIGATOR

Athraa S. Ahmed, M.B.CH.B

SUB_INVESTIGATOR

Mennatullah Fathi Ashour, Student

SUB_INVESTIGATOR

Mesan Hijazy

SUB_INVESTIGATOR

Mohammed Kamal Zubaidi, M.B.CH.B

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. In hospital mortality

    Time frame: In-Hospital Phase (average of 7 days through discharge)

    Mortality (death) during hospitalization

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulillah R. Khamees

CONTACT

[email protected]

+9647838571013

Sponsors and collaborators

Lead sponsor

Al-Nahrain University

Other

Registry information

Official study title

Can NISS or ISS Better Predict Mortality in Blunt Trauma Patients? A Prospective Study

Acronym: ISS/NISS/ER

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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