- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711276
Accuracy of the New Injury Severity Score in Evaluating Patients With Blunt Trauma (NISS/ER)
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:
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdulilh R. Khamis
- Phone Number: +9647838571013
- Email: allaabed987@ced.nahrainuniv.edu.iq
Study Locations
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Baghdad, Iraq
- Recruiting
- College of Medicine - Al-Nahrain University
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Principal Investigator:
- Abdul-Ilah R. Khamis
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Sub-Investigator:
- Saja J. Abotaleb, M.B.CH.B
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Sub-Investigator:
- Nabaa M. Ridha, M.B.CH.B
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Sub-Investigator:
- Osama N. Htitani, M.B.CH.B
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Sub-Investigator:
- Hassan H. ElAdl, Student
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Contact:
- Rawa'a A. Sattar A. Wahhab, MBBCH FICS CABMS FACS
- Phone Number: +9647821293356
- Email: dr.rawaaasattar@nahrainuniv.edu.iq
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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In hospital mortality
Time Frame: In-Hospital Phase (average of 6 days through discharge); Post-Discharge Follow-Up: Day 7, Day 30
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Mortality (death) during hospitalization.
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In-Hospital Phase (average of 6 days through discharge); Post-Discharge Follow-Up: Day 7, Day 30
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Accuracy Assessment of the New Injury Severity Score (NISS)
Time Frame: the first 6 hours after ER admission
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Range:0 to 75, with higher scores indicating worse outcomes and greater injury severity.
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the first 6 hours after ER admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospitalization
Time Frame: Up to discharge, an average of 6 days
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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.
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Up to discharge, an average of 6 days
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Number of Participants Requiring ICU Admission
Time Frame: Up to discharge, an average of 6 days
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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.
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Up to discharge, an average of 6 days
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The Number of Participants Who Require Surgical Intervention
Time Frame: Up to discharge, an average of 6 days
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need for surgical intervention during a trauma patient's hospital stay.
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Up to discharge, an average of 6 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rawa'a A. Sattar A. Wahhab, MBBCH FICS CABMS FACS, College Of Medicine - Nahrain University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNCOMIRB20241123B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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