Exploring the Epidemiology and Burden of Blunt Adrenal Gland Injury in the Context of Major Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Injury Severity Score (ISS)
研究概览
简要总结
Type: retrospective observational multicenter trial. Population of interest: adult patients suffering from thoraco-abdominal trauma undergoing both non-operative and operative management.
Hypothesis: Adrenal gland injury is a rare finding after blunt thoracoabdominal trauma. Short-term outcomes of blunt adrenal gland injury (BAGI) described in literature are contradictory. Reports on the outcomes related to this injury are variable and consider heterogeneous populations of trauma patients Aim: This study aims to explore the burden related to BAGI in an homogeneous population of patients sustaining blunt thoraco-abdominal trauma treated in different institution
详细描述
Adrenal gland injury is a rare finding after blunt thoracoabdominal trauma. The diagnosis can be accurately made with CT scan in stable patients, whilst in unstable patients, the detection can often be made during surgery, in the post-operative setting or postmortem. Short-term outcomes of blunt adrenal gland injury (BAGI) described in literature are contradictory. Studies reported BAGI as a high mortality risk injury. On the other hand, according to further reports, the presence of a BAGI is not considered a marker of severe injury or associated with an increased mortality rate.
Evidences the from a large multicenter cohort of selected trauma patients are lacking.
The study hypothesis is that BAGI is related to patients with higher trauma severity and worse overall outcome. By exploring the clinical burden related to BAGI the investigators aim to determine if this is related to the anatomical location of the injured organ or if in addition an underlying undisclosed pato-physiological mechanism is present. The investigatorspropose an international multicenter analysis on the epidemiology and the burden of BAGI in the context of major trauma, exploring differences between BAGI and non-BAGI patients.
Primary endpoint:
• Relationship between trauma severity (Injury Severity Score) of thoraco-abdominal trauma patients with BAGI versus torso trauma patients without BAGI
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 16 years old
- •All patients with blunt thoraco-abdominal trauma
排除标准
- •TBI with AIS > 3
- •Isolated TBI and Spinal cord injury
- •Patients died in emergency department
研究组 & 干预措施
BAGI
patients suffering from thoraco-abdominal blunt trauma with and without blunt adrenal gland injury
结局指标
主要结局
Injury Severity Score (ISS)
时间窗: 120 days after trauma
The Injury Severity Score (ISS) is an established medical score to assess trauma severity.It correlates with mortality, morbidity and hospitalization time after trauma. It is used to define the term major trauma. A major trauma (or polytrauma) is defined as the Injury Severity Score being greater than 15.The AIS Committee of the Association for the Advancement of Automotive Medicine (AAAM) designed and improves upon the scale. Injury Severity Score Minimum: 0 Maximum: 75 The risk of mortality and post trauma complications raises with increasing values in Injury Severity Score.
次要结局
- Overall survival(120 days)
- Overall length of stay at ICU(120 days)
- Organ Injury Scale of the blunt adrenal trauma(OIS)(120 days)
- Presence and number of thoraco-abdominal injuries(120 days)
- Overall length of stay(120 days)