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TraumaNISS/ERNCT06711276

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

An observational study of Trauma, run by Al-Nahrain University at 1 site in Iraq.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trauma
How many people
210 participants
Where
1 siteIraq
Study dates
10 Jan 2025to 15 Jul 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iraq1 site, 1 recruiting
  • College of Medicine - Al-Nahrain University

    Baghdad

    Rawa'a A. Sattar A. Wahhab, MBBCH FICS CABMS FACS, +9647821293356, dr.rawaaasattar@nahrainuniv.edu.iq

    Abdul-Ilah R. Khamis

    Recruiting

Other trials in Iraq

About this study

Official title: A Prospective Evaluation of the New Injury Severity Score's Accuracy in Blunt Trauma Patients

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:

Read more

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.

Read the detailed description

Trauma is the leading cause of death among individuals under 45 years of age, who represent the most productive population of society. According to the World Health Organization, trauma will remain a major driver of years of productive life lost by the end of this decade. Blunt trauma, a common form of injury, typically results in solid organ damage rather than hollow organ injuries.

Trauma management protocols play a vital role in reducing mortality. For example, standardized resuscitation protocols have been shown to decrease mortality by 15% in severely injured patients. The Airway, Breathing, Circulation, Disability, Exposure (ABCDE) approach is a clinically proven framework for managing trauma patients, improving patient outcomes, optimizing team performance, and saving time during life-threatening emergencies. In addition to standardized protocols, scoring systems play a critical role in evaluating the severity of trauma and predicting patient outcomes.

The Injury Severity Score (ISS), introduced in 1974, is one of the most widely used anatomical scoring systems. It evaluates the severity of injuries by dividing the body into six regions: head and neck, face, thorax, abdomen, extremities (including pelvis), and external. Each injury is assigned a score using the Abbreviated Injury Scale (AIS), but only the highest AIS score from each region is used. The ISS is then calculated as the sum of the squares of the top three AIS scores, with a maximum value of 75. Patients with an AIS score of 6 in any region are automatically assigned the maximum ISS score.

However, ISS has limitations. By considering only the most severe injury per body region, which may underestimate the severity of trauma in patients with multiple injuries in the same region. To address this, Osler et al. developed the New Injury Severity Score (NISS) in 1997. Unlike ISS, NISS accounts for the total of squares of the three most severe injuries, regardless of their location in the body, providing a more comprehensive assessment of trauma severity. Studies have shown that NISS often results in higher scores compared to ISS, offering better predictions of patient outcomes in multiple trauma cases.

In addition to anatomical scoring systems like ISS and NISS, physiological scoring systems have been developed to predict outcomes in trauma patients. The Revised Trauma Score (RTS) evaluates physiological parameters, incorporating the Glasgow Coma Scale, systolic blood pressure, and respiratory rate to assess trauma severity and predict mortality.

Research Gap and Study Rationale Although the benefits of NISS over ISS are well-documented globally, there is a lack of localized research evaluating its utility in predicting clinical outcomes in blunt trauma patients in Iraq. Existing studies primarily focus on high-income countries with established healthcare infrastructure, leaving a gap in understanding how such scoring systems perform in resource-limited and post-conflict settings like Iraq.

This study seeks to address this gap by evaluating the predictive accuracy of NISS for blunt trauma patients within Iraq. By assessing the sensitivity, specificity, and overall utility of NISS in the Iraqi healthcare context, this research aims to provide evidence-based recommendations to improve trauma care protocols and patient outcomes. The findings could inform policy development and foster the adoption of standardized trauma assessment tools, thereby strengthening Iraq's healthcare system.

Conditions
Trauma
Keywords
NISS, Trauma, ER, Death
Medical subject headings
Wounds and Injuries, Death

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In hospital mortality

    Mortality (death) during hospitalization.

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

  2. Accuracy Assessment of the New Injury Severity Score (NISS)

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

    Measured: the first 6 hours after ER admission

Secondary outcomes (3)
  1. Length of Hospitalization

    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.

    Measured: Up to discharge, an average of 6 days

  2. Number of Participants Requiring ICU Admission

    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.

    Measured: Up to discharge, an average of 6 days

  3. The Number of Participants Who Require Surgical Intervention

    need for surgical intervention during a trauma patient's hospital stay.

    Measured: Up to discharge, an average of 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start10 Jan 2025
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion15 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06711276
Sponsor's protocol ID
UNCOMIRB20241123B
Acronym
NISS/ER
Status last verified
Mar 2025
First submitted
23 Nov 2024
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 4814394
  • 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.

    PubMed 22319249
  • 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.

    PubMed 15345989
  • 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.

    PubMed 31086450
  • 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.

    PubMed 25015031
  • 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.

    PubMed 9420106
  • 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.

    PubMed 29121653
  • 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.

    PubMed 25189444
  • 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.

    PubMed 16508498
  • 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.

    PubMed 25332759
  • 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.

    PubMed 21794108

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma, run by Al-Nahrain University at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abdulilh R. Khamis (+9647838571013, allaabed987@ced.nahrainuniv.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In hospital mortality (time frame: In-Hospital Phase (average of 6 days through discharge); Post-Discharge Follow-Up: Day 7, Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06711276, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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