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Clinical Trials/NCT06705959
NCT06705959
Recruiting
Not Applicable

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

Al-Nahrain University1 site in 1 country200 target enrollmentStarted: April 28, 2025Last updated:
ConditionsTrauma

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Al-Nahrain University
Enrollment
200
Locations
1
Primary Endpoint
In hospital mortality

Overview

Brief 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.

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Length of Hospitalization(Up to discharge, an average of 7 days)
  • The requirement for admission to the intensive care unit (ICU)(Up to discharge, an average of 7 days)

Investigators

Sponsor
Al-Nahrain University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdul-Ilah R. Khamis

Principal Investigator

Al-Nahrain University

Study Sites (1)

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