Predictors of In-Hospital Mortality in Severe Abdominal Trauma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorMinia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

430 Participants
are grouped into 1 trial group
Group A: Severe abdominal trauma

Trial outcomes

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.

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

Secondary outcomes

1

Early (24-hour) mortality

Death from any cause within 24 hours of admission, reported as a proportion of enrolled patients.

Time frame
First 24 hours after admission
2

Intensive-care-unit mortality

Death occurring during the intensive-care admission, reported as a proportion of patients admitted to intensive care.

Time frame
From ICU admission to ICU discharge or death, assessed up to 90 days
3

Activation of the massive transfusion protocol

Proportion of patients in whom the institutional massive transfusion protocol is activated. Massive transfusion is defined as 10 or more units of packed red cells within 24 hours, or 4 or more units within 1 hour.

Time frame
First 24 hours after admission
4

Total 24-hour transfusion requirement

Total number of units of packed red cells transfused within 24 hours of admission, reported as median with interquartile range.

Time frame
First 24 hours after admission

Other outcomes

1

Discrimination of the derived multivariable model

Area under the receiver-operating-characteristic curve (AUROC) with 95% confidence interval for the multivariable logistic regression model predicting in-hospital mortality, reported as apparent and bootstrap optimism-corrected estimates (1,000 replicates).

Time frame
At completion of enrolment and database lock, up to 12 months after study start
2

Calibration of the derived multivariable model

Calibration assessed by the Hosmer-Lemeshow goodness-of-fit test and by calibration slope and intercept from a calibration plot, with bootstrap optimism correction.

Time frame
At completion of enrolment and database lock, up to 12 months after study start
3

Comparative discrimination against established trauma scores

Difference in AUROC between the derived model and the Injury Severity Score, Revised Trauma Score, TRISS and MGAP score, tested by the DeLong method for correlated ROC curves.

Time frame
At completion of enrolment and database lock, up to 12 months after study start
4

Performance of a simplified bedside risk score

Where the multivariable model is robust and well calibrated, a simplified integer score will be derived by assigning points proportional to the regression coefficients; its AUROC, calibration and risk-stratum-specific predicted mortality will be reported with internal bootstrap validation.

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

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