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PolytraumaNCT06653816

Comparing Exponential Injury Severity Score (EISS) With Injury Severity Score (ISS) and New Injury Severity Score (NISS)

An observational study of Polytrauma, run by Assiut University at 1 site in Egypt.

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

Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention. Polytrauma is a short verbal equivalent commonly used for severely injured patients usually with associated injury (i.e., two or more severe injuries in at least two different areas… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Polytrauma
How many people
250 participants
Where
1 siteEgypt
Study dates
1 Nov 2024to Nov 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 to 80 years
  • All sexes
  • Adult, Older adult

Study population: traumatic patients with multiple trauma of both genders "without intently selected certain gender" and had 18 years old or more.

Who may be able to join

  • traumatic patients with multiple trauma, both genders "without intently selected certain gender" and had 18 years old or more.

Who cannot join

  • Patients who are less than 18 years old.
  • Patients with end stage chronic disease .
  • Patients with localized individual trauma will be excluded from this study.
  • Patients refusing study .

Trial locations and contacts

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

Mohamed F Mohamed Moussa contact

+201120764046

mohamed.15248393@med.aun.edu.eg

Egypt1 site, 1 recruiting
  • Assiut University Hospitals

    Asyut

    Mohamed F Mohamed, Resident, 00201120764046, Mohamed.15248393@med.aun.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Comparing the New Exponential Injury Severity Score (EISS) With the Injury Severity Score (ISS) and the New Injury Severity Score (NISS) in Polytrauma Patients for Survival Prediction and ICU Admission in Assiut University Hospitals

Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention. Polytrauma is a short verbal equivalent commonly used for severely injured patients usually with associated injury (i.e., two or more severe injuries in at least two different areas of the body), less often with a multiple injury (i.e., two or more severe injuries in one body area). Polytrauma patients usually have a much higher risk of mortalities and disabilities than the risk of expected mortalities in individual injuries patients.

Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group. Approximately 5.8 million people die each year due to trauma related injuries, representing 8% of the worldwide mortality.

Read more

For studying the outcomes of trauma, accurate and reliable methodological tools are required for appropriate scoring of severity and outcome prediction.

Trauma scores were designed to facilitate the triage of patients in the Emergency Room (ER) and identify patients with Polytrauma with low chances of survival. Those scores were meant to organize and improve the quality of trauma care systems, and to assess resources allocation.

Trauma patients present to the emergency department (ED) with a great variety of injuries and diseases. To address these, the Abbreviated Injury Scale (AIS) system defines the severity of injury throughout the different regions of the body. It is an anatomically based, consensus derived, global severity scoring system that classifies an individual injury by body region according to its relative severity on a 6-point scale (1 = minor and 6 = maximal). The system is constantly revised, expanded, and improved, and the Association for the Advancement of Automotive Medicine recently announced its latest revision, the AIS 2005-Update 2008 and AIS 2015. To summarize a single patient's multiple injures into a single score, the Injury Severity Score (ISS) was created by Baker et al. in 1974, which has been considered the "gold standard" among anatomic injury severity indicators. It is based on the AIS severity values, that is, the summation of the squares of the severity digit in the AIS of the most severe injuries, in three of six predefined body regions.

However, the ISS only includes one injury in each body region, which leads to possible inclusion of a less severe injury in other body regions rather than another serious injury in the same body region. To overcome this limitation, a modified ISS, the New Injury Severity Score (NISS) was introduced by Osler et al. in 1997. NISS is simply the sum of squares of the three most severe injuries, regardless of the body regions injured.

Further, Wang et al. have created the Exponential Injury Severity Score (EISS) in 2014 by modifying the AIS system. The EISS was computed as the simple change in AIS values by raising each AIS severity score (1-6) by 3 taking a power of AIS minus 2, and then summing the three most severe scores (i.e., highest AIS values), regardless of body regions. With this exponential transformation of the AIS values, the EISS is expected to be more reflective of the true severity of injuries in a patient with polytrauma. In Wang's study, the EISS is reported to be more predictive of survival; therefore, it might be used as the standard summary measure of human trauma.

Read the detailed description

Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention. Polytrauma is a short verbal equivalent commonly used for severely injured patients usually with associated injury (i.e., two or more severe injuries in at least two different areas of the body), less often with a multiple injury (i.e., two or more severe injuries in one body area). Polytrauma patients usually have a much higher risk of mortalities and disabilities than the risk of expected mortalities in individual injuries patients.

Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group. Approximately 5.8 million people die each year due to trauma related injuries, representing 8% of the worldwide mortality.

Even though polytrauma can occur due to different causes such as road traffic accidents, fall from heights, bullet injuries, suicide, and homicide. Yet the leading cause of traumatic related causes of death worldwide is road traffic accidents. Egypt has experienced an alarming increase in the burden of traumatic injuries. In 2015, according to the World Health Organization, Egypt had one of the highest rates of road accidents worldwide, with more than 12,000 fatalities each year, one of the highest among Eastern Mediterranean Region (EMR) countries.

Although 90% of world's road trauma related fatalities occur in low- and middle-income countries, Injury prevention and trauma care programs in these countries have remained deficient.

For studying the outcomes of trauma, accurate and reliable methodological tools are required for appropriate scoring of severity and outcome prediction. Trauma scores were designed to facilitate the triage of patients in the Emergency Room (ER) and identify patients with Polytrauma with low chances of survival. Those scores were meant to organize and improve the quality of trauma care systems, and to assess resources allocation.

More than 50 scoring systems have been published for the classification of trauma patients in the field, emergency room, and intensive care settings. There are three main groups of trauma scores: Anatomical, Physiological, and Combined scores. Anatomical scores describe all the injuries recorded by clinical examination, imaging, surgery or autopsy and measure lesion severity {ex. Abbreviated Injury Scale (AIS) - Injury Severity Score (ISS) - New Injury Severity Score (NISS) -Organ Injury Scale (OIS) - Anatomic Profile -International Classification of Diseases (ICD-9) Injury Severity Score (ICISS)}. Physiological scores describe changes happened due to the trauma and translated by changes in vital signs and consciousness {ex. Revised Trauma Score - Glasgow Coma Score - APACHE scoring (Acute Physiology and Chronic Health Evaluation - (APACHE I, II, III) -Rapid Emergency Medicine Score (REMS)}. Combined scores include both anatomical and physiological criteria {ex. Trauma and Injury Severity Scores (TRISS) - A Severity Characterization of Trauma (ASCOT)-Kampala Trauma Score (KTS)}.

Trauma patients present to the emergency department (ED) with a great variety of injuries and diseases. To address these, the Abbreviated Injury Scale (AIS) system defines the severity of injury throughout the different regions of the body. It is an anatomically based, consensus derived, global severity scoring system that classifies an individual injury by body region according to its relative severity on a 6-point scale (1 = minor and 6 = maximal). The system is constantly revised, expanded, and improved, and the Association for the Advancement of Automotive Medicine recently announced its latest revision, the AIS 2005-Update 2008 and AIS 2015. To summarize a single patient's multiple injures into a single score, the Injury Severity Score (ISS) was created by Baker et al. in 1974, which has been considered the "gold standard" among anatomic injury severity indicators. It is based on the AIS severity values, that is, the summation of the squares of the severity digit in the AIS of the most severe injuries, in three of six predefined body regions.

However, the ISS only includes one injury in each body region, which leads to possible inclusion of a less severe injury in other body regions rather than another serious injury in the same body region. To overcome this limitation, a modified ISS, the New Injury Severity Score (NISS) was introduced by Osler et al. in 1997. NISS is simply the sum of squares of the three most severe injuries, regardless of the body regions injured.

Further, Wang et al. have created the Exponential Injury Severity Score (EISS) in 2014 by modifying the AIS system. The EISS was computed as the simple change in AIS values by raising each AIS severity score (1-6) by 3 taking a power of AIS minus 2, and then summing the three most severe scores (i.e., highest AIS values), regardless of body regions. With this exponential transformation of the AIS values, the EISS is expected to be more reflective of the true severity of injuries in a patient with polytrauma. In Wang's study, the EISS is reported to be more predictive of survival; therefore, it might be used as the standard summary measure of human trauma.

The aim of this study is to compare the ability of the new Exponential Injury Severity Score (EISS) with that of the Injury Severity Score (ISS) and the New Injury Severity Score (NISS) to identify patients at risk of in-hospital mortality or ICU admission and predict survival in Assiut University Hospitals.

Conditions
Polytrauma
Keywords
EISS, NISS, ISS
Medical subject headings
Multiple Trauma

What is being measured

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

  1. Mortality rate

    Mortality "death" during the 30 day follow-up

    Measured: 30 days

Secondary outcomes (3)
  1. Rate of Intensive Care Unit admission

    Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department

    Measured: Day 0

  2. Rate of hospital admission

    Admission to hospital from the Emergency Department

    Measured: Day 0

  3. Rate of readmission in the Emergency Department

    Re-visits to the Emergency Department after the index-visit.

    Measured: Hour 72, Day 30

Timeline

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

  1. First posted22 Oct 2024
  2. Study start1 Nov 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionNov 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
Case only
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06653816
Sponsor's protocol ID
EISS-NISS-ISS
Status last verified
Dec 2024
First submitted
21 Oct 2024
Last updated
6 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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
  • 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
  • Beuran M, Negoi I, Paun S, Runcanu A, Gaspar B, Vartic M. [Trauma scores: a review of the literature]. Chirurgia (Bucur). 2012 May-Jun;107(3):291-7. Romanian.

    PubMed 22844826
  • Guzzo JL, Bochicchio GV, Napolitano LM, Malone DL, Meyer W, Scalea TM. Prediction of outcomes in trauma: anatomic or physiologic parameters? J Am Coll Surg. 2005 Dec;201(6):891-7. doi: 10.1016/j.jamcollsurg.2005.07.013. Epub 2005 Oct 13.

    PubMed 16310692
  • Elachi IC, Yongu WT, Odoyoh OO, Mue DD, Ogwuche EI, Ahachi CN. An epidemiological study of the burden of trauma in Makurdi, Nigeria. Int J Crit Illn Inj Sci. 2015 Apr-Jun;5(2):99-102. doi: 10.4103/2229-5151.158404.

    PubMed 26157653
  • Bikbov B, Perico N, Remuzzi G. Mortality landscape in the global burden of diseases, injuries and risk factors study. Eur J Intern Med. 2014 Jan;25(1):1-5. doi: 10.1016/j.ejim.2013.09.002. Epub 2013 Sep 29.

    PubMed 24084027
  • Marsden NJ, Tuma F. Polytraumatized Patient. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554426/

    PubMed 32119313
  • Rau CS, Wu SC, Kuo PJ, Chen YC, Chien PC, Hsieh HY, Hsieh CH. Polytrauma Defined by the New Berlin Definition: A Validation Test Based on Propensity-Score Matching Approach. Int J Environ Res Public Health. 2017 Sep 11;14(9):1045. doi: 10.3390/ijerph14091045.

    PubMed 28891977
  • Cernea D, Novac M, Dragoescu PO, Stanculescu A, Duca L, Al-Enezy AA, Dragoescu NA. Polytrauma and Multiple Severity Scores. Curr Health Sci J. 2014 Oct-Dec;40(4):244-8. doi: 10.12865/CHSJ.40.04.02. Epub 2014 Dec 14.

    PubMed 26793320
  • Lendrum RA, Lockey DJ. Trauma system development. Anaesthesia. 2013 Jan;68 Suppl 1:30-9. doi: 10.1111/anae.12049.

    PubMed 23210554
  • 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
  • Wang MD, Fan WH, Qiu WS, Zhang ZL, Mo YN, Qiu F. The exponential function transforms the Abbreviated Injury Scale, which both improves accuracy and simplifies scoring. Eur J Trauma Emerg Surg. 2014 Jun;40(3):287-94. doi: 10.1007/s00068-013-0331-1. Epub 2013 Oct 5.

    PubMed 26816062

Questions about this trial

What is this clinical trial studying?

An observational study of Polytrauma, run by Assiut University at 1 site in Egypt.

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 1 inclusion and 4 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 6 Dec 2024. 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 Egypt. 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 Mohamed F Mohamed Moussa (+201120764046, mohamed.15248393@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality rate (time frame: 30 days). 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 NCT06653816, which also lists 12 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 6 Dec 2024.

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