Predictors of Mortality in Severe Abdominal Trauma: A Prospective Cohort From a Tertiary Center
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- In-hospital all-cause mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
In-hospital all-cause mortality
时间窗: 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.
次要结局
- 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)
- Major in-hospital complications(From admission to hospital discharge, assessed up to 90 days)
- Intensive-care length of stay(From admission to hospital discharge, assessed up to 90 days)
- Total hospital length of stay(From admission to hospital discharge, assessed up to 90 days)
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University