Clinical trial NCT06732791: Comparative Analysis of MGAP and GAP Trauma Scores in Predicting Outcomes for Multiple Trauma Patients
Official title: A Comparative Analysis of MGAP and GAP Trauma Scores in Predicting Prognosis for Multiple Trauma Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma
Keywords: MGAP
GAP
Lead sponsor: Al-Nahrain University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 522
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include patients presenting with multiple trauma to the Trauma and Emergency Department at Al-Kadhimiya Teaching Hospital, Iraq. This population comprises patients who have sustained injuries affecting multiple body regions and require urgent medical evaluation and management

Brief summary: The goal of this prospective cohort study is to compare the predictive accuracy of the MGAP and GAP trauma scores in determining the prognosis of multiple trauma patients admitted to the emergency department at Al-Kadhimiya Teaching Hospital, Iraq.

The main questions it aims to answer are:

Does the MGAP score provide a more accurate prediction of outcomes compared to the GAP score? Are there specific subgroups of trauma patients where one score demonstrates superior predictive utility over the other?

Participants will:

Be assessed using both the MGAP and GAP scores upon admission to the emergency department.

Have their clinical outcomes, including mortality, length of stay, and need for surgery, tracked throughout their hospital stay.

Detailed description: Lower-middle income countries (LMICs) pay the price of a growing volume of trauma, as collateral damage for development, rapid urbanization and sociodemographic transition. Trauma includes various types of injuries, which can be either penetrating or non-penetrating, typically categorized as unintentional (like those from road accidents, falls, drownings, and burns) or intentional (including self-inflicted harm and violence). According to the WHO Global Burden of Disease project, around one billion individuals require trauma-related healthcare each year, accounting for 12% of the total global disease burden. Trauma represents a significant global health challenge, causing more fatalities than HIV/AIDS, tuberculosis, malaria, and maternal mortality combined, with over five million deaths annually attributed to traumatic injuries. This makes trauma the fourth leading cause of death worldwide, and the WHO predicts a 40% increase in trauma-related fatalities by 2030, with nearly 90% of these deaths occurring in low and middle-income countries. Most trauma-related deaths happen shortly after the injury occurs, predominantly during the pre-hospital phase, which requires emergency service providers to quickly evaluate the patient's condition and the severity of the trauma to ensure proper referrals.

Research indicates that between 25% and 50% of trauma-related deaths are preventable. The mortality rate serves as the most reliable indicator of trauma prognosis, which can be assessed in two time frames: short-term (within 24 hours) and long-term (over four weeks). An efficient scoring system for trauma patients can assist physicians in rapidly and accurately evaluating injury severity and determining patient management. Timely intervention is crucial in trauma care, as providing swift and suitable treatment has been proven to reduce both mortality and morbidity rates consistently. Such prompt care depends on effective risk stratification in emergency settings. Currently, there are several trauma scoring systems available, each with differing accuracy and reliability for assessing morbidity and mortality risks in patients. Among these are the MGAP and GAP scores, which are simplified, physiologically-based scoring systems not yet widely implemented in low- and middle-income countries. The MGAP acronym stands for "mechanism of injury, GCS, age, and systolic blood pressure," and this score was initially developed in France as a pre-hospital triage tool to predict 30-day mortality. It has also been validated as effective in predicting prolonged ICU stays and major hemorrhages within a European demographic. The MGAP score has been adapted into the GAP score, which omits the injury mechanism for ease of use in clinical environments. GAP stands for "GCS, age, and systolic blood pressure," and it has been validated using data from the Japan Trauma Data Bank. Sartorius et al. determined in their research that the MGAP score can effectively predict the mortality rate of hospitalized trauma patients. Similarly, Yutaka Kondo et al. found that the GAP score can reliably predict the mortality rate of trauma patients in a hospital setting.

Despite advancements in trauma care, predicting outcomes for multiple trauma patients remains a critical challenge in clinical settings, particularly in low-resource environments like Iraq. There is a concerning scarcity of studies within the Iraqi context that evaluate the validity and reliability of scoring systems tailored to the region's unique demographic and healthcare landscape. This underscores the urgent need for comprehensive research to assess the efficacy of the MGAP and GAP Trauma Scores in predicting outcomes for multiple trauma patients in Iraq. Therefore, this study aims to evaluate the effectiveness, reliability, and accuracy of the MGAP and GAP Trauma Scores in assessing the severity of injuries and predicting outcomes for a diverse population of multiple trauma patients.

Eligibility criteria: Inclusion Criteria:

* Aged 16 years or older.
* Patients presenting with multiple trauma (Multiple trauma is defined as injuries involving two or more body regions or organ systems that might need coordinated multidisciplinary management).
* Patients presenting to the emergency department within 6 hours of sustaining trauma.
* Patients or their legal representatives must provide informed consent for participation in the study.

Exclusion Criteria:

* Transfers from other facilities with interventions that may affect GAP or MGAP reliability.
* Pregnant women.
* Burn injuries represent the primary mechanism of trauma.
* Incomplete records or failure of follow-up
* Patients who are deceased upon arrival at the emergency department.
* Patient discharge against medical advice.

Primary outcomes:
measure: In hospital mortality
timeFrame: In-Hospital Phase (average of 7-10 days through discharge)
measure: Accuracy Assessment of the MGAP score
timeFrame: the first 4 hours after ER admission
measure: Accuracy Assessment of the GAP score
timeFrame: the first 4 hours after ER admission
Secondary outcomes:
measure: Length of Hospitalization
timeFrame: Up to discharge, an average of 7-10 days
measure: Need for 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: Mohammad A. Hamdawi, Lecturer of general surgery
role: STUDY_DIRECTOR
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