NCT06709547

Brief Summary

The goal of this prospective cohort study is to compare the predictive utility of the Injury Severity Score (ISS), New Injury Severity Score (NISS), Revised Trauma Score (RTS), and Trauma and Injury Severity Score (TRISS) in determining mortality outcomes among trauma patients admitted to the trauma and emergency department at Kadhimiya Educational Hospital in Baghdad. The main questions it aims to answer are: Which trauma scoring system provides the most accurate prediction of mortality? Are there specific trauma patient subgroups where one scoring system outperforms the others? Participants will: Be assessed using all four trauma scoring systems (ISS, NISS, RTS, and TRISS) upon admission to the trauma and emergency department. Have their clinical outcomes, including mortality, length of hospital stay, ICU admission, and discharge status, monitored throughout their hospital stay to evaluate the accuracy and utility of each scoring system in predicting patient outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

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

November 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

November 23, 2024

Last Update Submit

April 27, 2025

Conditions

Keywords

ISSNISSRTSTISS

Outcome Measures

Primary Outcomes (5)

  • In hospital mortality

    Mortality (death) during hospitalization

    In-Hospital Phase (average of 7 days through discharge)

  • Accuracy Assessment of Injury Severity Score (ISS)

    Range: 0 to 75 Higher values indicate worse outcomes, reflecting greater injury severity.

    the first 12 hours after ER admission

  • Accuracy Assessment of New Injury Severity Score (NISS)

    Range: 0 to 75. Higher values indicate worse outcomes, reflecting greater injury severity.

    the first 12 hours after ER admission

  • Accuracy Assessment of Trauma Injury Severity Score (TISS)

    Range: 0 (represents a 0% probability of survival) to 1 (represents a 100% probability of survival), with higher scores indicating greater trauma severity.

    the first 12 hours after ER admission

  • Accuracy Assessment of the Revised Trauma Score (RTS)

    The total RTS score ranges from 0 to approximately 12, with lower scores indicating more severe injuries and a higher risk of mortality.

    the first 12 hours after ER admission

Secondary Outcomes (3)

  • Length of Hospitalization

    Up to discharge, an average of 7 days

  • Number of Participants Requiring ICU Admission

    Up to discharge, an average of 7 days

  • Number of Participants Requiring Surgical Intervention

    Up to discharge, an average of 7 days

Eligibility Criteria

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

The study population consists of adult trauma patients (≥18 years) presenting to the trauma and emergency department at Kadhimiya Educational Hospital in Baghdad. It includes individuals with acute injuries, such as blunt or penetrating trauma, who require trauma severity scoring. Data will be gathered through standardized clinical assessments and trauma scoring within the emergency department setting, ensuring a representative sample of the trauma population at the hospital.

You may qualify if:

  • Trauma patients admitted to the emergency room (ER).
  • Documented injury data sufficient to calculate both the New Injury Severity Score (NISS) and the Injury Severity Score (ISS).
  • Trauma scores (ISS, NISS, Revised Trauma Score \[RTS\], and Trauma and Injury Severity Score \[TRISS\]) calculated within 12 hour of arrival to ensure timely predictions.
  • Informed consent provided by the patient or a legal guardian in cases of incapacity.

You may not qualify if:

  • Under 18 years of age and pregnant women, due to differences in trauma management and scoring applicability.
  • Non-trauma cases, including patients with terminal illnesses or severe cognitive impairments, to maintain focus on trauma outcomes.
  • Incomplete trauma scoring, missing or incomplete medical records, and
  • patients not treated in the trauma or emergency department.
  • Patients who refuse participation or withdraw consent to ensure ethical participation.
  • Transferred patients and those enrolled in other research studies that could interfere with trauma scoring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Iraq

RECRUITING

Related Publications (6)

  • Senkowski CK, McKenney MG. Trauma scoring systems: a review. J Am Coll Surg. 1999 Nov;189(5):491-503. doi: 10.1016/s1072-7515(99)00190-8. No abstract available.

    PMID: 10549738BACKGROUND
  • Champion HR, Sacco WJ, Copes WS, Gann DS, Gennarelli TA, Flanagan ME. A revision of the Trauma Score. J Trauma. 1989 May;29(5):623-9. doi: 10.1097/00005373-198905000-00017.

    PMID: 2657085BACKGROUND
  • 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
  • Hoke MH, Usul E, Ozkan S. Comparison of Trauma Severity Scores (ISS, NISS, RTS, BIG Score, and TRISS) in Multiple Trauma Patients. J Trauma Nurs. 2021 Apr-Jun 01;28(2):100-106. doi: 10.1097/JTN.0000000000000567.

  • Boyd CR, Tolson MA, Copes WS. Evaluating trauma care: the TRISS method. Trauma Score and the Injury Severity Score. J Trauma. 1987 Apr;27(4):370-8.

  • 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.

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 23, 2024

First Posted

November 29, 2024

Study Start

January 28, 2025

Primary Completion

December 1, 2025

Study Completion

December 15, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations