Accuracy of the New Injury Severity Score in Evaluating Patients With Blunt Trauma

NCT06711276 | Recruiting DMC

• 1 other identifier: UNCOMIRB20241123B
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective observational study is to evaluate the predictive utility of the New Injury Severity Score (NISS) in determining mortality outcomes among blunt trauma patients admitted to the Emergency Department of Kadhimiya Educational Hospital, Iraq. The main questions it aims to answer are: How accurately does NISS predict mortality in blunt trauma patients? What is the performance of NISS in predicting secondary outcomes, such as the need for intensive care and length of hospital stay? Participants will: Be assessed using the NISS score upon their admission to the emergency department. Have their clinical outcomes, including mortality, need for intensive care, and hospital stay, monitored throughout their hospitalization.

Conditions

Trauma

Keywords

NISS; Trauma; ER; Death

Outcome Measures

Primary Outcomes (2)

• In hospital mortality

  Mortality (death) during hospitalization.

  In-Hospital Phase (average of 6 days through discharge); Post-Discharge Follow-Up: Day 7, Day 30

• Accuracy Assessment of the New Injury Severity Score (NISS)

  Range:0 to 75, with higher scores indicating worse outcomes and greater injury severity.

  the first 6 hours after ER admission

Secondary Outcomes (3)

• Length of Hospitalization

  Up to discharge, an average of 6 days

• Number of Participants Requiring ICU Admission

  Up to discharge, an average of 6 days

• The Number of Participants Who Require Surgical Intervention

  Up to discharge, an average of 6 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 presenting to the Emergency Department of Al-Kadhmia Teaching Hospital during the study period. These patients will represent a diverse demographic and clinical profile, including individuals with different injury mechanisms such as motor vehicle accidents, falls, assaults, and sports-related injuries, as well as varying injury severities and outcomes. The study will specifically focus on patients for whom the New Injury Severity Score (NISS) can be reliably applied. This includes patients with blunt trauma, where injury severity can be accurately assessed using clinical and radiological data.

You may qualify if:

• Trauma patients admitted to the emergency department, presenting with blunt trauma, such as from motor vehicle accidents, falls, or assaults.
• Patients with adequate documentation of anatomical injuries and physiological parameters required for NISS calculation.
• Injury assessment and NISS calculation completed within the first 6 hours of arrival to ensure accuracy and consistency in trauma evaluation.

You may not qualify if:

• Patients under 18 years, pregnant women, or those with pre-existing medical conditions that may alter trauma scoring accuracy or management outcomes.
• Patients presenting with medical emergencies, terminal illnesses, or conditions unrelated to blunt trauma to ensure focus on trauma-specific evaluations.
• Patients declared dead on arrival or who do not receive active treatment in the emergency department.
• Patients or their families refusing participation or withdrawing consent at any stage of the study.
• Patients transferred from or to another facility or those previously treated elsewhere, as this may affect data collection and scoring reliability.

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Iraq

RECRUITING

Related Publications (11)

• Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.

  PMID: 4814394 BACKGROUND

• Thim T, Krarup NH, Grove EL, Rohde CV, Lofgren B. Initial assessment and treatment with the Airway, Breathing, Circulation, Disability, Exposure (ABCDE) approach. Int J Gen Med. 2012;5:117-21. doi: 10.2147/IJGM.S28478. Epub 2012 Jan 31.

  PMID: 22319249 BACKGROUND

• van Olden GD, Meeuwis JD, Bolhuis HW, Boxma H, Goris RJ. Advanced trauma life support study: quality of diagnostic and therapeutic procedures. J Trauma. 2004 Aug;57(2):381-4. doi: 10.1097/01.ta.0000096645.13484.e6.

  PMID: 15345989 BACKGROUND

• Javali RH, Krishnamoorthy, Patil A, Srinivasarangan M, Suraj, Sriharsha. Comparison of Injury Severity Score, New Injury Severity Score, Revised Trauma Score and Trauma and Injury Severity Score for Mortality Prediction in Elderly Trauma Patients. Indian J Crit Care Med. 2019 Feb;23(2):73-77. doi: 10.5005/jp-journals-10071-23120.

  PMID: 31086450 RESULT

• Rapsang AG, Shyam DC. Scoring systems of severity in patients with multiple trauma. Cir Esp. 2015 Apr;93(4):213-21. doi: 10.1016/j.ciresp.2013.12.021. Epub 2014 Jul 8. English, Spanish.

  PMID: 25015031 RESULT

• Osler T, Baker SP, Long W. A modification of the injury severity score that both improves accuracy and simplifies scoring. J Trauma. 1997 Dec;43(6):922-5; discussion 925-6. doi: 10.1097/00005373-199712000-00009.

  PMID: 9420106 RESULT

• Kuo SCH, Kuo PJ, Chen YC, Chien PC, Hsieh HY, Hsieh CH. Comparison of the new Exponential Injury Severity Score with the Injury Severity Score and the New Injury Severity Score in trauma patients: A cross-sectional study. PLoS One. 2017 Nov 9;12(11):e0187871. doi: 10.1371/journal.pone.0187871. eCollection 2017.

  PMID: 29121653 RESULT

• Eid HO, Abu-Zidan FM. New Injury Severity Score is a better predictor of mortality for blunt trauma patients than the Injury Severity Score. World J Surg. 2015 Jan;39(1):165-71. doi: 10.1007/s00268-014-2745-2.

  PMID: 25189444 RESULT

• Celso B, Tepas J, Langland-Orban B, Pracht E, Papa L, Lottenberg L, Flint L. A systematic review and meta-analysis comparing outcome of severely injured patients treated in trauma centers following the establishment of trauma systems. J Trauma. 2006 Feb;60(2):371-8; discussion 378. doi: 10.1097/01.ta.0000197916.99629.eb.

  PMID: 16508498 RESULT

• Mehta N, Babu S, Venugopal K. An experience with blunt abdominal trauma: evaluation, management and outcome. Clin Pract. 2014 Jun 18;4(2):599. doi: 10.4081/cp.2014.599. eCollection 2014 Jun 18.

  PMID: 25332759 RESULT

• van der Vlies CH, Olthof DC, Gaakeer M, Ponsen KJ, van Delden OM, Goslings JC. Changing patterns in diagnostic strategies and the treatment of blunt injury to solid abdominal organs. Int J Emerg Med. 2011 Jul 27;4:47. doi: 10.1186/1865-1380-4-47.

  PMID: 21794108 RESULT

Related Links

• Lefering, R. Trauma Score Systems for Quality Assessment. Eur J Trauma 28, 52-63 (2002).

MeSH Terms

Conditions

Wounds and Injuries; Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rawa'a A. Sattar A. Wahhab, MBBCH FICS CABMS FACS

  College Of Medicine - Nahrain University

  STUDY DIRECTOR

Central Study Contacts

Abdulilh R. Khamis

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: December 2, 2024
• Study Start: January 10, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 15, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)