Blunt ADrenal Gland injUrY (BAD GUY) Project (BADGUY)

Exploring the Epidemiology and Burden of Blunt Adrenal Gland Injury in the Context of Major Trauma

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

Study Overview

• Status: Recruiting
• Conditions: Trauma; Adrenal Gland Injury

Detailed Description

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

Secondary endpoint:

• Organ Injury Scale of the blunt adrenal trauma(OIS), overall survival, ICU length of stay, overall length of stay

Methods:

Patients will be enrolled according to the reported criteria. The following variables will be considered: - Demographic (age, sex, comorbidities) - Mechanism of trauma - Trauma bay and surgical management - Trauma severity (ISS, NISS, OIS, AIS) - Need for ventilation (Y/N, timing) - Data on vasoactive support - Post trauma clinical and laboratory parameters - Mortality - Length of stay (ICU, hospital) All information of patients will be extracted from our dedicated Trauma Registry and personal informations will be removed according to data anonymization, and collected in an electronic database.

Data will be reported in accordance with Strengthening the Reporting of Observational studies in Epidemiology guidelines (STROBE) for observational studies.

Statistical analysis A 1:1 propensity score matching analysis will be performed based on sex, setting of the trauma, trauma mechanism, age, ASA classification, intentionality of the trauma, Glasgow coma scale and Revised Trauma Score. Following the propensity score matching patients included with and without BAGI will be compared using χ2 test for categorical variables and t-student test or Mann-Whitney test according to sample distribution for continuous variables

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Stefano P Cioffi, MD; Phone Number: +3386032519; Email: stefanopiero.cioffi@ospedaleniguarda.it
• Study Contact Backup: Name: Laura Benuzzi, MD; Email: laura.benuzzi@unimi.it

Study Locations

• Italy
  • Lombardy
    • Miano, Lombardy, Italy, 20162
      • Recruiting
      • ASST GOM Niguarda
      • Contact: Stefano Cioffi, MD; Phone Number: +393386032519; Email: stefanopiero.cioffi@ospedaleniguarda.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients presenting to ED diagnosed with acute appendicitis and eligible for laparoscopic appendectomy

Description

Inclusion criteria:

• Age > 16 years old
• All patients with blunt thoraco-abdominal trauma

Exclusion criteria:

• TBI with AIS > 3
• Isolated TBI and Spinal cord injury
• Patients died in emergency department

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
BAGI; patients suffering from thoraco-abdominal blunt trauma with and without blunt adrenal gland injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injury Severity Score (ISS)	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.	120 days after trauma

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence and number of thoraco-abdominal injuries	The presence of a specific organ injury per each thoraco-abdominal organ will be registered, defining the presence of an injury as a dichotomous variable (0 absent, 1 present)	120 days
Organ Injury Scale of the blunt adrenal trauma(OIS)	The presence of a blunt adrenal gland injury will be registered and classified following the America Association for Surgery of Trauma Organ Injury Scale classification as follow: I Contusion II Laceration involving only cortex (<2 cm) III Laceration extending into medulla (> 2 cm) IV >50% parenchymal destruction V Total parenchymal destruction (including massive intraparenchymal hemorrhage) Avulsion from blood supply	120 days
Overall length of stay	The length of stay in the hospital will be recorded considering it as the time frame, in days, from patient's admission to the emergency department to death or to the discharge to home or a rehabilitation service	120 days
Overall survival	The final outcome of the patient at 120 days will be registered as a dichotomous variable (0 survived, 1 dead)	120 days
Overall length of stay at ICU	The length of stay in the Intensive Care Unit will be recorded considering it as the time frame, in days, from patient's admission in the ICU to death or to the discharge to a surgical or medical ward	120 days

Collaborators and Investigators

• Sponsor: Niguarda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 20, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Trauma; major trauma; blunt adrenal gland trauma
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: BD-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No