Clinical trial NCT06732752: Evaluating the New Trauma Score (NTS) for Improved Mortality Prediction
Official title: Prospective Validation of the New Trauma Score (NTS) for Superior Prediction of Mortality Compared to the Revised Trauma Score
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Trauma
Keywords: RTS
Lead sponsor: Al-Nahrain University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 177
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: consist of trauma patients admitted to the emergency department (ED) of Al-Kadhimiya Teaching Hospital over the study period. This will include both male and female patients of various age groups who present with trauma-related injuries.

Brief summary: The goal of this prospective cohort study is to evaluate the predictive accuracy of the New Trauma Score (NTS), a modification of the Revised Trauma Score (RTS), in determining mortality outcomes among trauma patients admitted to the emergency department at Al-Kadhimiya Teaching Hospital, Iraq.

The main questions it aims to answer are:

Does the NTS provide a more accurate prediction of mortality than the RTS? Are there specific subgroups of trauma patients where the NTS demonstrates superior predictive utility compared to the RTS?

Participants will:

Be assessed using both the NTS and RTS upon admission to the emergency department.

Have their clinical outcomes, including mortality, tracked throughout their hospital stay.

Detailed description: Trauma is increasingly being a cause of mortality globally. Every year, over 45 million people suffer moderate to severe disability as a result of trauma, making them the leading cause of mortality among persons aged 18 to 29. According to the World Health Organization (WHO), road traffic injuries caused 1.25 million deaths in 2014, and trauma is predicted to become the third biggest cause of disability globally by 2030. Accurate management and time are vital factors in the treatment of traumatic patients and play a main role in determining the outcome of trauma patients. Patients with serious traumatic injuries have a significantly lower likelihood of mortality or morbidity when treated at a designated trauma center.

Trauma scoring systems are simple to inform physicians of the severity of trauma in patients and help them decide the course of trauma management. They can be used in the field to determine whether to send a patient to a trauma center before they arrive at the hospital. When a trauma patient has just arrived at the emergency department (ED), they might also be utilized for clinical decision-making. Trauma scoring systems can be used in the emergency department to prepare the patient for surgery, to call on medical staff for trauma support, and to tell the patient's family of the severity of the patient's condition at an early stage. A scoring system must be accurate, reliable, and specific to predict trauma-related death.

As a result, trauma scores could be physiological, which detail changes in vital signs and state of awareness, such as the New Trauma Score (NTS) and Revised Trauma Score (RTS), which enable early clinical assessment of patients at admission. Anatomical, which describes the extent and number of anatomical lesions, such as the Abbreviated Injury Scale (AIS) and Injury Severity Score (ISS), allowing for later clinical assessment, including imaging after initial patient stabilization, surgery, and autopsy. combined, such as Trauma and Injury Severity Score (TRISS) and KTS, which incorporate RTS and ISS. The combined trauma ratings are especially useful in assessing the prognosis after trauma. Physiological NTS and combined KTS were developed primarily for their applicability in resource-constrained environments where advanced initial evaluation for anatomical lesions using computerized tomographic (CT) scans and magnetic resonance imaging (MRI) may not be available.

The New Trauma Score (NTS) is gaining popularity as an improved measure for predicting trauma mortality. It was created as a modification of the Revised Trauma Score (RTS) to enhance accuracy and usability. Compared to RTS, NTS includes extra measures such as oxygen saturation (SpO2) instead of respiratory rate, uses the actual Glasgow Coma Scale (GCS) score rather than coded values, and revise the systolic blood pressure interval used for the code value.These changes make the score more dynamic and suitable for a wider range of trauma settings.

Recent studies have validated the effectiveness of NTS. For instance, it demonstrated superior sensitivity in predicting mortality compared to the Kampala Trauma Score II (KTS II), though KTS II showed slightly higher specificity. NTS also performed well against other tools like MGAP and GAP, highlighting its balance between simplicity and precision. These features make it particularly useful in prehospital and emergency department triage systems, where rapid and reliable decisions are critical for patient outcomes.

Eligibility criteria: Inclusion Criteria:

* All trauma patients (including blunt, penetrating, and traumatic brain injury) admitted to the emergency department.
* Patients presenting with varying degrees of trauma (mild to severe).
* Patients (or their legal representatives) who provide informed consent to participate in the study.
* Trauma patients admitted to the emergency department.
* Patients who are assessed using both the Revised Trauma Score (RTS) and the New Trauma Score (NTS) upon admission to the emergency department.

Exclusion Criteria:

* Patients under 18 years old.
* Pregnant women, due to the potential complications and challenges in trauma assessment.
* Patients who refuse to give consent to participate in the study or whose legal guardians refuse on their behalf.
* Trauma patients transferred from other hospitals.
* Patients with incomplete medical records or missing key data required for trauma score calculation.

Primary outcomes:
measure: In hospital mortality
timeFrame: In-Hospital Phase (average of 7 days through discharge); Post-Discharge Follow-Up: Day 7, Day 30
measure: Accuracy Assessment of the New Trauma Score (NTS)
timeFrame: the first 6 hours after ER admission
measure: Accuracy Assessment of the Revised Trauma Score (RTS)
timeFrame: the first 6 hours after ER admission
Secondary outcomes:
measure: Length of Hospitalization
timeFrame: Up to discharge, an average of 7 days
measure: Need for ICU Admission
timeFrame: Up to discharge, an average of 7 days
measure: Need for Surgical Intervention
timeFrame: Up to discharge, an average of 7 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
References:
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