NCT07848776

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Oct 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Oct 2026Dec 2026

First Submitted

Initial submission to the registry

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 23, 2026

Last Update Submit

September 29, 2026

Conditions

Keywords

traumaintensive carehospital mortalityprognostic modelexternal validationGAPMGAPNew Trauma Score of TriageTunisia

Outcome Measures

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.

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

Secondary Outcomes (2)

  • Calibration and Local Recalibration of GAP, MGAP, and T-NTS for All-Cause In-Hospital Mortality

    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

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

Study Arms (1)

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.

Other: Trauma mortality prediction scores: GAP, MGAP, and T-NTS

Interventions

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.

Adult Trauma ICU Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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

You may qualify if:

  • 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.
  • The intensive care unit admission belonged to the continuous acute hospitalization following the index injury.

You may not qualify if:

  • 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.
  • Elective, reconstructive, rehabilitation, or late readmission after discharge from the acute trauma hospitalization.
  • Iatrogenic injury or procedural complication without qualifying external blunt or penetrating trauma.
  • Duplicate record or ICU readmission within the same trauma hospitalization.
  • A later eligible trauma episode in a patient already included during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and InjuriesCritical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology and Intensive Care Medicine

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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