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PolytraumaNCT05544773

Comparing Trauma Severity Scores Injury Severity Score "ISS", Rapid Emergency Medicine Score "REMS" and Kampala Trauma Score "KTS"

An observational study of Polytrauma, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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.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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Polytrauma
How many people
250 participants
Where
No sites listed yet
Study dates
1 Oct 2022to 1 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • 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 .

About this study

Official title: Comparing Trauma Severity Scores Injury Severity Score "ISS", Rapid Emergency Medicine Score "REMS" and Kampala Trauma Score "KTS" in Polytrauma Patients for Survival Prediction and ICU Admission in Assiut and Suez Canal University Hospitals.

Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention.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.

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 ER (emergency room), 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.3 12 In 1969, Researchers developed the Abbreviated Injury Scale (AIS) to grade the severity of individual injuries. Attempting to summarize injury severity in patients with multiple traumas with a single number is almost difficult; therefore, multiple alternative scoring systems were proposed afterwards, each with its own problems and limitations.

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: (a) Anatomical, (b) Physiological, (c) Combined scores. Anatomical scores describe all the injuries recorded by clinical examination, imaging, surgery or autopsy and measure lesion severity. Physiological scores describe changes happened due to the trauma, and translated by changes in vital signs and consciousness. Scores that include both anatomical and physiological criteria (mixed scores) are more useful for patient prognosis

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.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.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. Even though polytrauma can occur due to different causes such as road traffic accidents, fall from heights, bullet injuries, suicide and homicide7.Yet the leading cause of traumatic related causes of death worldwide is road traffic accidents.8 Egypt, in particular, has experienced an alarming increase in the burden of traumatic injuries. According to the World Health Organization In 2015 Egypt has one of the highest rates of road accidents worldwide, with more than 12,000 fatalities each year, one of the highest among 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 ER (emergency room), 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. In 1969, Researchers developed the Abbreviated Injury Scale (AIS) to grade the severity of individual injuries. Attempting to summarize injury severity in patients with multiple traumas with a single number is almost difficult; therefore, multiple alternative scoring systems were proposed afterwards, each with its own problems and limitations.

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: (a) Anatomical, (b) Physiological, (c) Combined scores.

Anatomical scores describe all the injuries recorded by clinical examination, imaging, surgery or autopsy and measure lesion severity. Physiological scores describe changes happened due to the trauma, and translated by changes in vital signs and consciousness. Scores that include both anatomical and physiological criteria (mixed scores) are more useful for patient prognosis

The three types of scores can be combined in different ways to obtain more accurate information from all the possible aspects141- Anatomical Scoring Systems: 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) 2- Physiological Scoring Systems: Revised trauma score - Glasgow coma score - APACHE scoring (Acute physiology and chronic health evaluation - (APACHE I, II, III) -Rapid Emergency Medicine Score (REMS)3- Combined Anatomical and Physiological Scoring Systems :Trauma and injury severity scores (TRISS) - A severity characterization of trauma (ASCOT)-Kampala Trauma Score (KTS)

What does each score mean? Injury Severity Score (ISS): The injury severity score (ISS) is an anatomical scoring system which provides an overall score for patients with multiple injuries. Each injury is assigned an abbreviated injury scale (AIS) score and allocated to one of six body regions. The highest AIS score of each body region is used. The three most severely injured body regions scores are squared and added together to produce the ISS score.

Rapid Emergency Medicine Score (REMS): Rapid Emergency Medicine Score (REMS) is a newly developed scoring system developed to overcome drawbacks of other scoring systems. It is a simplified version of the APACHE II that allows for rapid score calculation. The REMS is calculated based on the patient's Glasgow Coma Scale (GCS), respiratory rate (RR), oxygen saturation, mean arterial pressure (MAP), heart rate (HR), and age.

Kampala Trauma Score (KTS): A new severity score, Kampala Trauma Score (KTS), was introduced as an injury severity score in settings without advanced diagnostics. This is a simplified composite of the Revised Trauma Score (RTS) and the Injury Severity Score (ISS). The KTS has been validated for its ability to predict outcome in the Ugandan trauma registry.

Conditions
Polytrauma
Medical subject headings
Multiple Trauma

What is being measured

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

  1. Mortality

    Mortality "death" during the 30 day follow-up

    Measured: 30 days

Secondary outcomes (3)
  1. Hospital admission

    Admission to hospital from the Emergency Department

    Measured: Day 0

  2. Intensive Care Unit admission

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

    Measured: Day 0

  3. 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 posted16 Sep 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Oct 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
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05544773
Sponsor's protocol ID
ISS-REMS-KTS
Status last verified
Sep 2022
First submitted
11 Sep 2022
Last updated
16 Sep 2022
Results posted
No
Individual data sharing
Undecided

Publications

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

    PubMed 23210554
  • UF Health U of FH. Traumatic Injury. Published October 12, 2016. Accessed August 20, 2022. https://ufhealth.org/traumatic-injury

  • 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
  • World Health Organization. Injuries and violence. Published March 19, 2021. Accessed August 20, 2022. https://www.who.int/news-room/fact-sheets/detail/injuries-and-violence

  • 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
  • Marsden NJ, Tuma F. Polytraumatized Patient. StatPearls ; 2022. Accessed August 20, 2022. https://www.ncbi.nlm.nih.gov/books/NBK554426/

  • 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
  • The Global Road Safety Facility (GRSF), World Health Organization. Egypt's Road Safety Country Profile. Published 2016. Accessed August 20, 2022. https://www.roadsafetyfacility.org/country/egypt

  • 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
  • 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
  • Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.

    PubMed 3928249
  • Le Gall JR. The use of severity scores in the intensive care unit. Intensive Care Med. 2005 Dec;31(12):1618-23. doi: 10.1007/s00134-005-2825-8. Epub 2005 Oct 22. No abstract available.

    PubMed 16244878
  • 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
  • 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
  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Polytrauma, run by Assiut University.

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 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (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 NCT05544773, which also lists 18 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 16 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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