Comparing NISS and ISS for Mortality Prediction in Trauma Patients

NCT06705959 | Recruiting DMC

• 1 other identifier: UNCOMIRB20241122
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Keywords

NISS; ISS; Trauma; ER

Outcome Measures

Primary Outcomes (3)

• In hospital mortality

  Mortality (death) during hospitalization

  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.

  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.

  the first 6 hours after ER admission

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Iraq

RECRUITING

Related Publications (8)

• 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.

  PMID: 26283084 RESULT

• 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.

  PMID: 31558277 RESULT

• 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.

  PMID: 12941232 RESULT

• 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.

  PMID: 33667204 RESULT

• 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.

  PMID: 11804251 RESULT

• 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.

  PMID: 27537902 RESULT

• 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.

  PMID: 22964071 RESULT

• 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.

  PMID: 38049903 RESULT

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Anees K Nile, Professor of general surgery

  College Of Medicine - Nahrain University

  STUDY DIRECTOR

Central Study Contacts

Abdulillah R. Khamees

CONTACT

+9647838571013; allaabed987@ced.nahrainuniv.edu.iq

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: April 28, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 15, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)