Abdominal InjuriesNCT07843628
Predictors of In-Hospital Mortality in Severe Abdominal Trauma
An observational study of Abdominal Injuries and Wounds and Injuries, run by Minia University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Abdominal Injuries, Wounds and Injuries, Wounds, Nonpenetrating
- How many people
- 430 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospitals /Trauma unit- Department of Surgery, Faculty of Medicine, Minia University
Minya, Minya Governorate, 61519
Saleh K Saleh, MD, 01201765401 ext. +2, salehkhairy@mu.edu.eg
About this study
Official title: Predictors of Mortality in Severe Abdominal Trauma: A Prospective Cohort From a Tertiary Center
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.
Read more
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.
Read the detailed description
Background and rationale Trauma is among the leading causes of death and disability worldwide and the foremost cause of mortality in the first four decades of life. The abdomen is involved in a substantial proportion of severe injuries, and abdominal trauma contributes disproportionately to early haemorrhagic death and to late mortality from sepsis and multi-organ dysfunction. Outcomes are determined by the interplay of injury anatomy, physiological reserve, the timeliness and adequacy of resuscitation, and the surgical and critical-care response. Existing instruments that quantify this risk - the anatomical Injury Severity Score (ISS), the physiological Revised Trauma Score (RTS), the combined TRISS, and simpler bedside tools such as MGAP - were predominantly derived and calibrated in high-income trauma systems, and their transferability to high-volume centres in resource-constrained settings is uncertain. Reliance on imported risk estimates may misclassify risk, distort benchmarking, and provide limited guidance for triage, activation of massive transfusion, and the choice between definitive repair and damage-control surgery.
Knowledge gap Despite an extensive trauma-scoring literature, there are few prospective single-centre data from high-volume tertiary trauma units in low- and middle-income settings that (i) focus specifically on severe abdominal trauma rather than polytrauma in aggregate, (ii) capture early dynamic physiological and biochemical markers (lactate, base deficit, coagulopathy indices) alongside anatomical grading, and (iii) directly compare locally derived predictors against established scores using contemporary prediction-model methodology with internal validation.
Objectives Primary objective: to identify independent predictors of in-hospital all-cause mortality among patients presenting with severe abdominal trauma at a tertiary trauma centre. Secondary objectives: to describe the demographic, mechanistic, physiological, biochemical and anatomical-injury profile of the cohort and compare survivors with non-survivors; to quantify the discrimination (AUROC) and calibration of a multivariable model built from routinely available admission and early in-hospital variables; to compare the derived model with ISS, RTS, TRISS and MGAP; to describe secondary outcomes (24-hour mortality, intensive-care mortality, massive transfusion, damage-control surgery, major complications and length of stay) and their association with candidate predictors; and, where statistically supported, to derive a simplified, internally validated bedside risk score.
Hypothesis A defined set of admission and early in-hospital variables - in particular age, depth of physiological derangement (systolic blood pressure, shock index, Glasgow Coma Scale), metabolic markers of shock (lactate, base deficit), coagulopathy, transfusion intensity and anatomical injury burden - are independently associated with in-hospital mortality, and a model combining these variables achieves discrimination at least comparable to established trauma scores in this population.
Design and setting Single-centre, prospective observational cohort study conducted in the Emergency Trauma Unit and Department of Surgery of Minia University Hospitals, Minia, Egypt - a tertiary referral centre with 24-hour emergency surgical, interventional-radiology, blood-bank and intensive-care services, receiving both primary presentations and referrals from secondary facilities. Consecutive eligible patients are enrolled at admission and followed until hospital discharge or in-hospital death. No study-mandated intervention is applied. Reporting follows the STROBE statement, and the prediction-model component additionally follows TRIPOD.
Variables and data sources Candidate predictors were selected a priori on the basis of biological plausibility, established association with trauma mortality, and routine availability at admission or during the first hours of care. They span six domains: demographic (age, sex, relevant comorbidity); mechanism and prehospital (blunt versus penetrating and sub-type, time from injury to arrival, direct versus referred arrival); arrival physiology (systolic blood pressure, heart rate, shock index, Glasgow Coma Scale, respiratory rate, oxygen saturation, temperature); admission biochemistry and haematology (arterial lactate, base deficit, pH, haemoglobin, platelet count, INR); anatomical injury (AIS-abdomen, ISS, number of injured intra-abdominal organs, organ-specific AAST grade, major vascular injury, associated extra-abdominal injury, eFAST and estimated haemoperitoneum); and resuscitation and operative management (time from arrival to operation, massive transfusion, 24-hour packed-red-cell units, damage-control surgery, vasopressor requirement). Data are collected prospectively on a standardised case-report form and cross-checked against the emergency record, operative notes, laboratory and imaging systems, blood-bank record and intensive-care chart, with daily verification by a dedicated coordinator. AAST grading is assigned by the operating surgeon and verified against imaging by a second reviewer, and ISS, RTS, TRISS and MGAP are computed by an investigator blinded to eventual outcome wherever feasible.
Sample size The sample size is driven by the requirements of multivariable prediction modelling rather than a single hypothesis test. Institutional volume is approximately 250 patients with severe abdominal trauma annually, so 12-month enrolment is expected to yield close to 430 evaluable patients. Anticipating in-hospital mortality of approximately 20%, 430 patients generate an expected 86 deaths; applying at least ten events per variable supports a model containing up to eight independent predictors, and the final model will be constrained to eight or fewer variables. Using contemporary sample-size criteria for clinical prediction models (anticipated C-statistic approximately 0.80, outcome prevalence 0.20, up to 12 candidate parameters considered), the minimum required sample is below 400; the planned 430 provides a margin of roughly 10% for incomplete data.
Statistical analysis Continuous variables will be summarised as mean with standard deviation or median with interquartile range according to distribution (Shapiro-Wilk), and categorical variables as frequencies and percentages, overall and stratified by the primary outcome. Survivors and non-survivors will be compared using the independent-samples t-test or Mann-Whitney U test and the chi-square or Fisher exact test. Variables associated with mortality at p < 0.10, together with predictors judged clinically essential a priori, will enter a multivariable binary logistic regression model with in-hospital mortality as the dependent variable. Linearity of the logit will be checked and collinearity screened using variance-inflation factors. Adjusted odds ratios with 95% confidence intervals will be reported, with two-sided significance at p < 0.05.
Model performance, validation and score derivation Discrimination will be quantified by the area under the receiver-operating-characteristic curve and calibration by the Hosmer-Lemeshow test and a calibration plot. Internal validation will use bootstrap resampling with 1,000 replicates to derive optimism-corrected estimates. The derived model will be compared with ISS, RTS, TRISS and MGAP using the DeLong test for correlated AUROCs. If the model is robust and well calibrated, a simplified integer risk score will be derived by assigning points proportional to the regression coefficients, internally validated by the same bootstrap procedure, and reported with risk strata and corresponding predicted mortality.
Missing data, sensitivity and subgroup analyses The pattern and extent of missing data will be reported. Where a variable has less than 20% missing values assumed missing at random, multiple imputation by chained equations with pooling by Rubin's rules will be used, and a complete-case analysis reported as a sensitivity analysis. Further sensitivity analyses will examine 24-hour and intensive-care mortality as alternative endpoints and will repeat the primary analysis after excluding early deaths occurring within one hour. Pre-specified subgroup analyses will examine injury mechanism (blunt versus penetrating), age group (60 years and over versus under 60) and the presence of major vascular injury, assessed by interaction terms and interpreted with caution given reduced power. Analyses will be performed using SPSS version 27 or later and R version 4.3 or later (pROC, rms and mice packages).
Oversight and quality assurance As a non-interventional observational study that imposes no change to clinical care, a formal data and safety monitoring board is not required. A study oversight group comprising the principal investigator, a senior trauma surgeon and the study statistician will meet at least every six months to review recruitment, completeness and quality, and to approve protocol amendments before submission to the ethics committee. All investigators and data collectors complete structured training before enrolment begins. At least 10% of completed case-report forms will be independently source-verified by a team member not involved in the original entry, and inter-rater agreement for AIS and AAST grading will be quantified by Cohen's or weighted kappa on a random subset. Protocol deviations will be recorded in a deviation log.
Anticipated limitations As a single-centre study, findings may have limited generalisability to centres with different case mix, prehospital systems or resources, and external validation will be required before clinical adoption of any derived score. A prospective observational design cannot establish causation; identified predictors are markers of risk rather than necessarily modifiable causes of death. Some early deaths and prehospital variables may be incompletely captured. Internal validation by bootstrapping reduces but does not eliminate optimism. Referral patterns may introduce selection effects, as the most severely injured patients may die before reaching the centre.
- Conditions
- Abdominal Injuries, Wounds and Injuries, Wounds, Nonpenetrating, Wounds, Penetrating, Multiple Trauma, Shock, Hemorrhagic
- 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
- Medical subject headings
- Abdominal Injuries, Wounds and Injuries, Wounds, Nonpenetrating, Wounds, Penetrating, Multiple Trauma, Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission to hospital discharge or in-hospital death, assessed up to 90 days
Secondary outcomes (8)
Early (24-hour) mortality
Death from any cause within 24 hours of admission, reported as a proportion of enrolled patients.
Measured: First 24 hours after admission
Intensive-care-unit mortality
Death occurring during the intensive-care admission, reported as a proportion of patients admitted to intensive care.
Measured: From ICU admission to ICU discharge or death, assessed up to 90 days
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.
Measured: First 24 hours after admission
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.
Measured: First 24 hours after admission
Damage-control surgery and re-look laparotomy
Proportion of patients undergoing damage-control surgery, defined as an abbreviated initial laparotomy with planned re-look, and the number of re-look laparotomies per patient.
Measured: From admission to hospital discharge, assessed up to 90 days
Major in-hospital complications
Proportion of patients developing post-injury sepsis, acute kidney injury, acute respiratory distress syndrome, multi-organ dysfunction, surgical-site or intra-abdominal infection, or unplanned reoperation, reported individually and as a composite.
Measured: From admission to hospital discharge, assessed up to 90 days
Intensive-care length of stay
Number of days spent in the intensive care unit during the index admission, reported as median with interquartile range.
Measured: From admission to hospital discharge, assessed up to 90 days
Total hospital length of stay
Number of days from admission to hospital discharge, reported as median with interquartile range.
Measured: From admission to hospital discharge, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Oct 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843628
- Sponsor's protocol ID
- 2133:9/26
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Mortality in Severe Abdominal Trauma: A Prospective Cohort From a Tertiary Center
- ClinicalTrials.gov ID
- NCT07843628
- Acronym / sponsor ID
- 2133:9/26
- Conditions
- Abdominal Injuries, Wounds and Injuries, Wounds, Nonpenetrating, Wounds, Penetrating, Multiple Trauma, Shock, Hemorrhagic
- Keywords
- Abdominal trauma, Blunt abdominal trauma, Penetrating abdominal trauma, In-hospital mortality, Prediction model, Risk stratification, Shock index, Arterial lactate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and rationale Trauma is among the leading causes of death and disability worldwide and the foremost cause of mortality in the first four decades of life. The abdomen is involved in a substantial proportion of severe injuries, and abdominal trauma contributes disproportionately to early haemorrhagic death and to late mortality from sepsis and multi-organ dysfunction. Outcomes are determined by the interplay of injury anatomy, physiological reserve, the timeliness and adequacy of resuscitation, and the surgical and critical-care response. Existing instruments that quantify this risk - the anatomical Injury Severity Score (ISS), the physiological Revised Trauma Score (RTS), the combined TRISS, and simpler bedside tools such as MGAP - were predominantly derived and calibrated in high-income trauma systems, and their transferability to high-volume centres in resource-constrained settings is uncertain. Reliance on imported risk estimates may misclassify risk, distort benchmarking, and provide limited guidance for triage, activation of massive transfusion, and the choice between definitive repair and damage-control surgery.
Knowledge gap Despite an extensive trauma-scoring literature, there are few prospective single-centre data from high-volume tertiary trauma units in low- and middle-income settings that (i) focus specifically on severe abdominal trauma rather than polytrauma in aggregate, (ii) capture early dynamic physiological and biochemical markers (lactate, base deficit, coagulopathy indices) alongside anatomical grading, and (iii) directly compare locally derived predictors against established scores using contemporary prediction-model methodology with internal validation.
Objectives Primary objective: to identify independent predictors of in-hospital all-cause mortality among patients presenting with severe abdominal trauma at a tertiary trauma centre. Secondary objectives: to describe the demographic, mechanistic, physiological, biochemical and anatomical-injury profile of the cohort and compare survivors with non-survivors; to quantify the discrimination (AUROC) and calibration of a multivariable model built from routinely available admission and early in-hospital variables; to compare the derived model with ISS, RTS, TRISS and MGAP; to describe secondary outcomes (24-hour mortality, intensive-care mortality, massive transfusion, damage-control surgery, major complications and length of stay) and their association with candidate predictors; and, where statistically supported, to derive a simplified, internally validated bedside risk score.
Hypothesis A defined set of admission and early in-hospital variables - in particular age, depth of physiological derangement (systolic blood pressure, shock index, Glasgow Coma Scale), metabolic markers of shock (lactate, base deficit), coagulopathy, transfusion intensity and anatomical injury burden - are independently associated with in-hospital mortality, and a model combining these variables achieves discrimination at least comparable to established trauma scores in this population.
Design and setting Single-centre, prospective observational cohort study conducted in the Emergency Trauma Unit and Department of Surgery of Minia University Hospitals, Minia, Egypt - a tertiary referral centre with 24-hour emergency surgical, interventional-radiology, blood-bank and intensive-care services, receiving both primary presentations and referrals from secondary facilities. Consecutive eligible patients are enrolled at admission and followed until hospital discharge or in-hospital death. No study-mandated intervention is applied. Reporting follows the STROBE statement, and the prediction-model component additionally follows TRIPOD.
Variables and data sources Candidate predictors were selected a priori on the basis of biological plausibility, established association with trauma mortality, and routine availability at admission or during the first hours of care. They span six domains: demographic (age, sex, relevant comorbidity); mechanism and prehospital (blunt versus penetrating and sub-type, time from injury to arrival, direct versus referred arrival); arrival physiology (systolic blood pressure, heart rate, shock index, Glasgow Coma Scale, respiratory rate, oxygen saturation, temperature); admission biochemistry and haematology (arterial lactate, base deficit, pH, haemoglobin, platelet count, INR); anatomical injury (AIS-abdomen, ISS, number of injured intra-abdominal organs, organ-specific AAST grade, major vascular injury, associated extra-abdominal injury, eFAST and estimated haemoperitoneum); and resuscitation and operative management (time from arrival to operation, massive transfusion, 24-hour packed-red-cell units, damage-control surgery, vasopressor requirement). Data are collected prospectively on a standardised case-report form and cross-checked against the emergency record, operative notes, laboratory and imaging systems, blood-bank record and intensive-care chart, with daily verification by a dedicated coordinator. AAST grading is assigned by the operating surgeon and verified against imaging by a second reviewer, and ISS, RTS, TRISS and MGAP are computed by an investigator blinded to eventual outcome wherever feasible.
Sample size The sample size is driven by the requirements of multivariable prediction modelling rather than a single hypothesis test. Institutional volume is approximately 250 patients with severe abdominal trauma annually, so 12-month enrolment is expected to yield close to 430 evaluable patients. Anticipating in-hospital mortality of approximately 20%, 430 patients generate an expected 86 deaths; applying at least ten events per variable supports a model containing up to eight independent predictors, and the final model will be constrained to eight or fewer variables. Using contemporary sample-size criteria for clinical prediction models (anticipated C-statistic approximately 0.80, outcome prevalence 0.20, up to 12 candidate parameters considered), the minimum required sample is below 400; the planned 430 provides a margin of roughly 10% for incomplete data.
Statistical analysis Continuous variables will be summarised as mean with standard deviation or median with interquartile range according to distribution (Shapiro-Wilk), and categorical variables as frequencies and percentages, overall and stratified by the primary outcome. Survivors and non-survivors will be compared using the independent-samples t-test or Mann-Whitney U test and the chi-square or Fisher exact test. Variables associated with mortality at p < 0.10, together with predictors judged clinically essential a priori, will enter a multivariable binary logistic regression model with in-hospital mortality as the dependent variable. Linearity of the logit will be checked and collinearity screened using variance-inflation factors. Adjusted odds ratios with 95% confidence intervals will be reported, with two-sided significance at p < 0.05.
Model performance, validation and score derivation Discrimination will be quantified by the area under the receiver-operating-characteristic curve and calibration by the Hosmer-Lemeshow test and a calibration plot. Internal validation will use bootstrap resampling with 1,000 replicates to derive optimism-corrected estimates. The derived model will be compared with ISS, RTS, TRISS and MGAP using the DeLong test for correlated AUROCs. If the model is robust and well calibrated, a simplified integer risk score will be derived by assigning points proportional to the regression coefficients, internally validated by the same bootstrap procedure, and reported with risk strata and corresponding predicted mortality.
Missing data, sensitivity and subgroup analyses The pattern and extent of missing data will be reported. Where a variable has less than 20% missing values assumed missing at random, multiple imputation by chained equations with pooling by Rubin's rules will be used, and a complete-case analysis reported as a sensitivity analysis. Further sensitivity analyses will examine 24-hour and intensive-care mortality as alternative endpoints and will repeat the primary analysis after excluding early deaths occurring within one hour. Pre-specified subgroup analyses will examine injury mechanism (blunt versus penetrating), age group (60 years and over versus under 60) and the presence of major vascular injury, assessed by interaction terms and interpreted with caution given reduced power. Analyses will be performed using SPSS version 27 or later and R version 4.3 or later (pROC, rms and mice packages).
Oversight and quality assurance As a non-interventional observational study that imposes no change to clinical care, a formal data and safety monitoring board is not required. A study oversight group comprising the principal investigator, a senior trauma surgeon and the study statistician will meet at least every six months to review recruitment, completeness and quality, and to approve protocol amendments before submission to the ethics committee. All investigators and data collectors complete structured training before enrolment begins. At least 10% of completed case-report forms will be independently source-verified by a team member not involved in the original entry, and inter-rater agreement for AIS and AAST grading will be quantified by Cohen's or weighted kappa on a random subset. Protocol deviations will be recorded in a deviation log.
Anticipated limitations As a single-centre study, findings may have limited generalisability to centres with different case mix, prehospital systems or resources, and external validation will be required before clinical adoption of any derived score. A prospective observational design cannot establish causation; identified predictors are markers of risk rather than necessarily modifiable causes of death. Some early deaths and prehospital variables may be incompletely captured. Internal validation by bootstrapping reduces but does not eliminate optimism. Referral patterns may introduce selection effects, as the most severely injured patients may die before reaching the centre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital all-cause mortality
Time frame: From admission to hospital discharge or in-hospital death, assessed up to 90 days
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.
8 secondary outcomes
Early (24-hour) mortality
Time frame: First 24 hours after admission
Intensive-care-unit mortality
Time frame: From ICU admission to ICU discharge or death, assessed up to 90 days
Activation of the massive transfusion protocol
Time frame: First 24 hours after admission
Total 24-hour transfusion requirement
Time frame: First 24 hours after admission
Damage-control surgery and re-look laparotomy
Time frame: From admission to hospital discharge, assessed up to 90 days
Major in-hospital complications
Time frame: From admission to hospital discharge, assessed up to 90 days
Intensive-care length of stay
Time frame: From admission to hospital discharge, assessed up to 90 days
Total hospital length of stay
Time frame: From admission to hospital discharge, assessed up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Evaluation of the Blunt Abdominal Trauma Severity Score (BATSS) in Blunt Abdominal Trauma
Blunt Abdominal Trauma, Abdominal Injuries
Recruiting
A Research Study of Abdominal Ultrasound (FAST) in Children With Blunt Torso Trauma
Blunt Trauma to Abdomen, Wounds and Injuries
Recruiting
Open Lung Protective Extubation Following General Anesthesia
Intra-abdominal Surgery, Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saleh K Saleh, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Injuries and Wounds and Injuries, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saleh K Saleh, MD (01201765401 ext. +2, salehkhairy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital all-cause mortality (time frame: From admission to hospital discharge or in-hospital death, assessed up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.