Clinical trial NCT06711536: TRISS as a Predictor of Trauma Patient Outcomes
Official title: Evaluating the Trauma and Injury Severity Score (TRISS) as a Predictor of Patient Outcomes: A Prospective Observational Study in the Trauma and Emergency Department of Al-Kadhimiya Teaching Hospital, Iraq
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma, Multiple
Keywords: TRISS
Lead sponsor: Al-Nahrain University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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 represent a diverse demographic and clinical profile, encompassing individuals with varying injury mechanisms, severities, and outcomes.

The study specifically targets patients for whom trauma scoring systems, including the Trauma and Injury Severity Score (TRISS), can be applied reliably. This includes both blunt and penetrating trauma cases.

Brief summary: The goal of this prospective observational study is to evaluate the predictive utility of the Trauma and Injury Severity Score (TRISS) in determining patient outcomes, including survival and mortality, among trauma patients admitted to the trauma and emergency department of Kadhimiya Educational Hospital, Iraq.

The main questions it aims to answer are:

How accurately does TRISS predict survival and mortality outcomes in trauma patients? What is the performance of TRISS in predicting secondary outcomes, such as the need for intensive care, surgical interventions, and length of hospital stay?

Participants will:

Be assessed using the TRISS score upon their admission to the emergency department.

Have their clinical outcomes, including survival, need for intensive care, surgery, and hospital stay, monitored throughout their hospitalization.

Detailed description: Trauma is a significant cause of mortality and morbidity around the world. Approximately 10% of the burden of disease in adults is due to traumatic injuries. Trauma can lead to serious consequences, including disabilities, psychosocial burdens, and increased mortality among the actively working population. Cardiopulmonary arrest, unplanned admissions to intensive care units, and nosocomial infections are some complications faced by trauma patients admitted to trauma centers. The estimated mortality rate for hospitalized trauma patients is 11%. The in-hospital mortality rate for trauma patients who undergo cardiopulmonary resuscitation (CPR) is 92.7%. Trauma-related mortality and morbidity depend on injury severity, diagnostic delays, and the time taken to reach a medical facility.Timely evaluation, effective post-trauma care, and appropriate triage can significantly reduce long-term mortality and morbidity among trauma patients, with rapid assessment of trauma severity being crucial for the primary triage of multiple trauma patients.

Trauma scoring systems are valuable tools for quickly assessing the severity of injuries and predicting patient outcomes. By utilizing these scoring systems, healthcare providers can enhance the organization of trauma patient triage, optimize resource allocation, and conduct immediate evaluations of potential complications. Several scoring systems have been developed to assess trauma cases. These trauma scores are classified into three categories: anatomical (such as the Abbreviated Injury Scale and Injury Severity Score), physiological (like the Revised Trauma Score), and combined (such as the Trauma and Injury Severity Score). Physiological scores can be determined during the initial clinical assessment of the patient, while anatomical scoring can be performed later after the patient has been stabilized. This makes it easier to stratify trauma patients effectively. On the other hand, combined scores that include both anatomical and physiological criteria are more useful for patient prognosis. One such combined score is the Trauma and Injury Severity Score (TRISS), which was designed by the Major Trauma Outcome Study (MTOS) in the United States to predict the outcome in polytrauma patients and includes the Injury Severity Score (ISS) and Revised Trauma Score (RTS).

Trauma is thus now a significant health challenge in Iraq. Through the long fight in Iraq, more and more people are experiencing violence-related injuries, such as from firearms and attacks. The work also demonstrates that violence is one of the primary determinants of public health because it leads to complications with injuries and the psychological development of the survivors in the course of their lives. The Iraqi healthcare system has documented a significant rise in RTAs (road traffic accidents), particularly since the escalation of conflict around 2013. Trauma care system is not well established, and few protocols are followed clinically, and no scientific method is well established to predict the outcome in trauma patients in Iraq. This is made worse by scarce resources, inadequate staffing and educational preparedness of medical personnel, and the overall lack of formalized trauma registry databases that could well monitor patient results. In the Iraqi context, only a few studies have demonstrated the use of different trauma scores to predict outcomes in patients with trauma.

There is a significant research gap regarding the use of trauma scoring systems, especially TRISS, in Iraq. Most studies focus on descriptive outcomes rather than evaluating global trauma scores in the unique Iraqi context. Resource limitations, inconsistent pre-hospital care, and conflict-related injuries complicate the application of these systems. The lack of standardized trauma registries and data collection further limits the ability to improve trauma care and emergency services in Iraq.

Eligibility criteria: Inclusion Criteria:

* Trauma patients admitted to the emergency department of Al-Kadhimiya Teaching Hospital.
* Patients with adequate documentation of physiological and anatomical data are required for TRISS calculation.
* Trauma scoring (TRISS) completed within the first 6 hours of hospital arrival to ensure timely assessment.

Exclusion Criteria:

* Patients under 18 years, pregnant women, or those with conditions that alter standard trauma scoring or management.
* Non-trauma cases (e.g., medical emergencies, terminal illnesses) to ensure focus on trauma-specific outcomes.
* Patients with incomplete or missing data required for TRISS calculation.
* Patients declared dead on arrival or those not treated in the trauma and emergency department.
* Individuals refusing participation or withdrawing consent at any stage of the study.
* Patients transferred to or from another facility or enrolled in other studies that might affect scoring accuracy or outcomes.

Primary outcomes:
measure: In hospital mortality
timeFrame: In-Hospital Phase (average of 7-10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 30
measure: Accuracy Assessment of the Trauma and Injury Severity Score (TRISS)
timeFrame: the first 6 hours after ER admission
Secondary outcomes:
measure: Length of Hospitalization
timeFrame: Up to discharge, an average of 7-10 days
measure: Number of Participants Requiring ICU Admission
timeFrame: Up to discharge, an average of 7-10 days
measure: Need for Surgical Intervention
timeFrame: Up to discharge, an average of 7-10 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Medicine - Al-Nahrain University
Study officials:
affiliation: College Of Medicine - Nahrain University
name: Mohammed A. Hamdawi, Professor
role: STUDY_DIRECTOR
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