Clinical trial NCT06220448: Blunt ADrenal Gland injUrY (BAD GUY) Project
Official title: Exploring the Epidemiology and Burden of Blunt Adrenal Gland Injury in the Context of Major Trauma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma
Adrenal Gland Injury
Keywords: Trauma
blunt adrenal gland trauma
major trauma
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting to ED diagnosed with acute appendicitis and eligible for laparoscopic appendectomy

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Injury Severity Score (ISS)
timeFrame: 120 days after trauma
Secondary outcomes:
measure: Presence and number of thoraco-abdominal injuries
timeFrame: 120 days
measure: Organ Injury Scale of the blunt adrenal trauma(OIS)
timeFrame: 120 days
measure: Overall survival
timeFrame: 120 days
measure: Overall length of stay
timeFrame: 120 days
measure: Overall length of stay at ICU
timeFrame: 120 days
Other outcomes:
Locations:
city: Miano
country: Italy
facility: ASST GOM Niguarda
state: Lombardy
Study officials:
References: