Predictors of In-Hospital Mortality in Severe Abdominal Trauma

NCT07843628 | Recruiting DMC

• 1 other identifier: 2133:9/26
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

Severe abdominal trauma is a leading cause of early death from bleeding and of later death from sepsis and organ failure. Clinicians use scoring systems to estimate the risk of dying, but most of these scores were developed and calibrated in high-income trauma systems and may perform differently in high-volume referral hospitals elsewhere, where patients frequently arrive after a prehospital delay and already in established shock. This study will prospectively follow consecutive patients aged 16 years and older admitted to a single tertiary trauma centre with severe abdominal injury over a 12-month period. Severe abdominal trauma is defined as an Abbreviated Injury Scale score of 3 or more for the abdominal region, and/or an abdominal injury requiring emergency laparotomy, laparoscopy or angioembolisation, and/or admission to intensive care for management of an abdominal injury. A total of 430 evaluable patients is anticipated. Information generated as part of routine trauma care will be recorded prospectively from arrival until hospital discharge: age, sex and comorbidity; injury mechanism, time from injury to arrival and mode of arrival; arrival physiology (systolic blood pressure, heart rate, shock index, Glasgow Coma Scale, respiratory rate, oxygen saturation, temperature); admission biochemistry (arterial lactate, base deficit, pH, haemoglobin, platelet count, INR); imaging and operative findings with American Association for the Surgery of Trauma organ injury grades; transfusion and operative management; and in-hospital complications. The primary outcome is in-hospital all-cause mortality. Survivors and non-survivors will be compared, and a multivariable logistic regression model will be built to identify admission and early in-hospital variables that independently predict death. Model discrimination and calibration will be assessed and internally validated by bootstrap resampling, and performance will be compared with that of the Injury Severity Score, Revised Trauma Score, TRISS and the MGAP score. If the model is robust, a simplified integer bedside risk score will be derived and internally validated. The study is purely observational: it mandates no additional investigations, interventions or visits, and all clinical decisions remain with the attending trauma team according to institutional ATLS-based protocols. The findings are intended to support locally valid triage, transfusion and damage-control decision-making and to enable fair outcome benchmarking between comparable centres.

Conditions

Multiple Trauma; Shock, Hemorrhagic; Hospital Mortality; Abdominal Injuries; Wounds and Injuries; Wounds, Nonpenetrating; Wounds, Penetrating

Keywords

Abdominal trauma; Blunt abdominal trauma; Penetrating abdominal trauma; In-hospital mortality; Prediction model; Risk stratification; Shock index; Arterial lactate; Base deficit; Trauma-induced coagulopathy; Massive transfusion; Damage-control surgery; Injury Severity Score; Revised Trauma Score; TRISS; MGAP score; AAST organ injury scale

Outcome Measures

Primary Outcomes (1)

• In-hospital all-cause mortality

  Death from any cause occurring between hospital admission and hospital discharge, ascertained from the hospital record and reported as the proportion of enrolled patients who die before discharge. Analysed as the dependent variable in the multivariable prediction model.

  From admission to hospital discharge or in-hospital death, assessed up to 90 days

Secondary Outcomes (8)

• Early (24-hour) mortality

  First 24 hours after admission

• Intensive-care-unit mortality

  From ICU admission to ICU discharge or death, assessed up to 90 days

• Activation of the massive transfusion protocol

  First 24 hours after admission

• Total 24-hour transfusion requirement

  First 24 hours after admission

• Damage-control surgery and re-look laparotomy

  From admission to hospital discharge, assessed up to 90 days

Other Outcomes (4)

• Discrimination of the derived multivariable model

  At completion of enrolment and database lock, up to 12 months after study start

• Calibration of the derived multivariable model

  At completion of enrolment and database lock, up to 12 months after study start

• Comparative discrimination against established trauma scores

  At completion of enrolment and database lock, up to 12 months after study start

Study Arms (1)

Severe abdominal trauma

Consecutive patients aged 16 years or older admitted within 24 hours of injury with blunt or penetrating abdominal trauma meeting at least one severity criterion: AIS-abdomen of 3 or more; an abdominal injury requiring emergency laparotomy, laparoscopy or angioembolisation; or admission to intensive care for management of an abdominal injury. All patients receive standard trauma and post-operative care according to institutional ATLS-based protocols; the study allocates no intervention and does not influence management.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients aged 16 years and older presenting to the Emergency Trauma Unit of Minia University Hospitals, Minia, Egypt, within 24 hours of blunt or penetrating abdominal injury and meeting the protocol definition of severe abdominal trauma. The centre is a tertiary referral hospital serving a large catchment population and receives both primary presentations and referrals from secondary facilities.

You may qualify if:

• Age 16 years or older.
• Abdominal trauma, blunt or penetrating, meeting at least one criterion for severity: Abbreviated Injury Scale (AIS) for the abdominal region of 3 or more; and/or an abdominal injury requiring emergency laparotomy, laparoscopy or angioembolisation; and/or admission to the intensive care unit for management of an abdominal injury.
• Presentation within 24 hours of injury.
• Informed consent provided by the patient or, for incapacitated patients, by a legal representative, with deferred consent procedures as specified in the protocol.

You may not qualify if:

• Death on arrival, or within the first 15 minutes of admission before meaningful resuscitation or data capture.
• Isolated minor abdominal injury not meeting the severity definition (AIS-abdomen below 3 and not requiring operative or radiological intervention or critical-care admission).
• Transfer out of the centre before the primary outcome can be ascertained.
• Known pregnancy (managed on a separate obstetric-trauma pathway).
• Declined consent.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospitals /Trauma unit- Department of Surgery, Faculty of Medicine, Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

MeSH Terms

Conditions

Abdominal Injuries; Wounds and Injuries; Wounds, Nonpenetrating; Wounds, Penetrating; Multiple Trauma; Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)