Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Evaluation of Three Trauma Mortality Scores in Adults Admitted to Intensive Care in Tunisia (TICU-SCORES)

29 de septiembre de 2026 actualizado por: Sameh Ben Ahmed, University Tunis El Manar

External Validation and Local Recalibration of GAP, MGAP, and the New Trauma Score for Triage (T-NTS) for All-Cause In-Hospital Mortality in Adult Trauma Patients Admitted to Intensive Care in Tunisia: A Retrospective Cohort Study

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This single-centre retrospective cohort study will externally validate GAP, MGAP, and T-NTS in an ICU-selected adult trauma population at a tertiary hospital in Tunisia. All consecutive eligible adults physically admitted to the participating ICU during the fixed eight-year clinical window will be screened. Predictor values will be taken from the earliest qualified assessment after injury and before sedation, neuromuscular blockade, and tracheal intubation. The study therefore evaluates prognosis among trauma patients who reached intensive care and does not claim validation for triage of all emergency-department trauma patients.

The primary endpoint is death from any cause before live discharge from the continuous index admission to the study hospital. The primary comparison will use one common complete-case cohort with known outcome, age, mechanism, qualified Glasgow Coma Scale, systolic blood pressure, and peripheral oxygen saturation. Missing predictor values will not be imputed and will not change cohort eligibility; missingness and the flow from screened to eligible and analyzable participants will be reported.

Score discrimination will be summarized by area under the receiver operating characteristic curve with 95% confidence intervals and paired comparisons using DeLong's method. Observed mortality will be described within original score risk groups. Separate one-predictor logistic models will estimate local score-to-risk relationships, with 1,000 bootstrap resamples for internal validation. Mortality by calendar day 7 after index ICU admission will be a prespecified secondary endpoint if retained in the final signed protocol. No treatment, diagnostic procedure, or exposure is assigned by the investigators.

Tipo de estudio

De observación

Inscripción (Estimado)

1000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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

Descripción

Inclusion Criteria:

  1. Age 18 years or older at the earliest qualified assessment.
  2. Acute physical injury caused by a blunt or penetrating mechanism.
  3. Trauma or an immediate consequence of trauma was the principal reason for the first qualifying intensive care unit admission.
  4. The first qualifying intensive care unit admission occurred from 1 January 2018 through 31 December 2025, inclusive.
  5. The intensive care unit admission belonged to the continuous acute hospitalization following the index injury.

Exclusion Criteria:

  1. Age younger than 18 years.
  2. No physical admission to the participating intensive care unit, including death before ICU admission.
  3. Isolated burn, isolated inhalation injury, drowning, hanging, asphyxia, poisoning, or isolated thermal, electrical, or chemical injury without qualifying blunt or penetrating trauma.
  4. ICU admission for a medical condition when trauma was incidental and not the principal indication for critical care.
  5. Elective, reconstructive, rehabilitation, or late readmission after discharge from the acute trauma hospitalization.
  6. Iatrogenic injury or procedural complication without qualifying external blunt or penetrating trauma.
  7. Duplicate record or ICU readmission within the same trauma hospitalization.
  8. A later eligible trauma episode in a patient already included during the study period.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: RETROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Adult Trauma ICU Cohort

All consecutive eligible adults admitted to the participating intensive care unit because of acute blunt or penetrating trauma between 1 January 2018 and 31 December 2025. GAP, MGAP, and the New Trauma Score for Triage (T-NTS) will be calculated retrospectively from routinely recorded clinical data. No treatment or diagnostic procedure is assigned by the investigators.

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) 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Discrimination of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality
Periodo de tiempo: From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)

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.

From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Calibration and Local Recalibration of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality
Periodo de tiempo: From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)

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.

From index hospital presentation to in-hospital death or live discharge during the continuous index hospitalization (expected up to 12 months)
Discrimination of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality by Day 7
Periodo de tiempo: From index ICU admission through calendar day 7 (ICU admission date = day 0)

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.

From index ICU admission through calendar day 7 (ICU admission date = day 0)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: sameh ben ahmed, MD, Anesthesiology and Intensive Care Unit, Mohamed Taher Maamouri Teaching Hospital Faculty of Medicine of Tunis, University Tunis El Manar Mrezga, 8000 Nabeul, Tunisia

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

15 de diciembre de 2026

Finalización del estudio (Estimado)

15 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

23 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de septiembre de 2026

Publicado por primera vez (Actual)

30 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HTMM-TICU-SCORES-01
  • 59-2026 (Otro identificador: Comité d'éthique de l'Hôpital Mohamed Tahar Maâmouri)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant-level data extracted from confidential medical records will not be made publicly available. The data dictionary and statistical code may be shared with publication subject to ethics and institutional approval

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .