Evaluation of Three Trauma Mortality Scores in Adults Admitted to Intensive Care in Tunisia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Tunis El Manar
About this trial
The goal of this retrospective observational study is to learn how well three simple trauma scores predict death during the hospital stay in adults admitted to intensive care after an injury in Tunisia. The scores are the Glasgow Coma Scale, Age, and Systolic Blood Pressure score (GAP); the Mechanism, Glasgow Coma Scale, Age, and Systolic Blood Pressure score (MGAP); and the New Trauma Score for Triage (T-NTS). Researchers will review existing medical records for admissions from 1 January 2018 through 31 December 2025. They will not assign treatment or contact participants. The main question is how accurately the three scores distinguish participants who died in the hospital from those discharged alive. Secondary analyses will examine agreement between score-based risk and observed mortality and performance for mortality by day 7 after ICU admission.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older at the earliest qualified assessment.
Acute physical injury caused by a blunt or penetrating mechanism.
Trauma or an immediate consequence of trauma was the principal reason for the first qualifying intensive care unit admission.
The first qualifying intensive care unit admission occurred from 1 January 2018 through 31 December 2025, inclusive.
Disqualifiers
Age younger than 18 years.
No physical admission to the participating intensive care unit, including death before ICU admission.
Isolated burn, isolated inhalation injury, drowning, hanging, asphyxia, poisoning, or isolated thermal, electrical, or chemical injury without qualifying blunt or penetrating trauma.
ICU admission for a medical condition when trauma was incidental and not the principal indication for critical care.
Trial population
Adults aged 18 years or older who were physically admitted to the intensive care unit of Mohamed Tahar Maâmouri Hospital, Nabeul, Tunisia, because acute blunt or penetrating trauma, or an immediate consequence of that trauma, was the principal indication for critical care between 1 January 2018 and 31 December 2025. All consecutive potentially eligible admissions will be identified from the ICU registers and medical records. Only the first qualifying trauma episode and ICU admission per patient will be included. Eligible patients with missing score variables will remain in the eligible cohort but may not enter the common complete-case analysis
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Trauma mortality prediction scores: GAP, MGAP, and T-NTS
Other interventionThe Glasgow Coma Scale, Age, and Systolic Blood Pressure score (GAP); the Mechanism, Glasgow Coma Scale, Age, and Systolic Blood Pressure score (MGAP); and the New Trauma Score for Triage (T-NTS) will be calculated retrospectively using existing clinical information recorded before sedation, neuromuscular blockade, or tracheal intubation whenever available. The scores are evaluated as prognostic tools; they are not used to assign treatment or alter patient care.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Adult Trauma ICU Cohort1 intervention
Trial outcomes
Primary outcomes
1
Discrimination of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality
The clinical endpoint is death from any cause before live discharge from the continuous index admission to the study hospital. For each score, discrimination will be quantified by the area under the receiver operating characteristic curve (AUROC) with a 95% confidence interval in the common complete-case cohort. AUROC ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination). Correlated AUROCs will be compared using DeLong's method.
Time frame
From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)Secondary outcomes
1
Calibration and Local Recalibration of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality
Observed all-cause in-hospital mortality with 95% confidence intervals will be reported within the original risk groups of each score. For each score, a one-predictor logistic model relating the original total score to mortality will estimate a local score-to-risk relationship. Internal validation of the recalibration procedure will use 1,000 bootstrap resamples.
Time frame
From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)2
Discrimination of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality by Day 7
The clinical endpoint is death from any cause in the study hospital on or before calendar day 7 after the first qualifying ICU admission; the ICU admission date is day 0. The endpoint is derived from dates and is not an exact 168-hour measure. Discrimination of GAP, MGAP, and T-NTS will be summarized by AUROC with 95% confidence intervals; paired DeLong comparisons will be reported if the number of day-7 deaths is adequate.
Time frame
From index ICU admission through calendar day 7 (ICU admission date = day 0)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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