NCT06653816

Brief 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 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

October 21, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

EISSNISSISS

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    Mortality "death" during the 30 day follow-up

    30 days

Secondary Outcomes (3)

  • Rate of Intensive Care Unit admission

    Day 0

  • Rate of hospital admission

    Day 0

  • Rate of readmission in the Emergency Department

    Hour 72, Day 30

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, Egypt

RECRUITING

Related Publications (12)

  • 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: 29121653BACKGROUND
  • 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.

    PMID: 26816062BACKGROUND
  • 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: 9420106BACKGROUND
  • 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: 4814394BACKGROUND
  • 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.

    PMID: 22844826BACKGROUND
  • 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.

    PMID: 16310692BACKGROUND
  • 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.

    PMID: 26157653BACKGROUND
  • 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.

    PMID: 24084027BACKGROUND
  • Marsden NJ, Tuma F. Polytraumatized Patient. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554426/

    PMID: 32119313BACKGROUND
  • 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.

    PMID: 28891977BACKGROUND
  • 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.

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

    PMID: 23210554BACKGROUND

Related Links

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Mohamed F Mohamed Moussa

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 22, 2024

Study Start

November 1, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations