TraumaBADGUYNCT06220448
Blunt ADrenal Gland injUrY (BAD GUY) Project
An observational study of Trauma and Adrenal Gland Injury, run by Niguarda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Trauma, Adrenal Gland Injury
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 30 Sep 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 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients presenting to ED diagnosed with acute appendicitis and eligible for laparoscopic appendectomy
Who may be able to join
- Age > 16 years old
- All patients with blunt thoraco-abdominal trauma
Who cannot join
- TBI with AIS > 3
- Isolated TBI and Spinal cord injury
- Patients died in emergency department
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Benuzzi, MD contact
Italy1 site, 1 recruiting
- Recruiting
ASST GOM Niguarda
Miano, Lombardy, 20162
Stefano Cioffi, MD, +393386032519, stefanopiero.cioffi@ospedaleniguarda.it
About this study
Official title: 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
Read the 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
- Conditions
- Trauma, Adrenal Gland Injury
- Keywords
- Trauma, blunt adrenal gland trauma, major trauma
- Medical subject headings
- Wounds and Injuries
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 |
|---|---|---|
| BAGI | patients suffering from thoraco-abdominal blunt trauma with and without blunt adrenal gland injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days after trauma
Secondary outcomes (5)
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)
Measured: 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
Measured: 120 days
Overall survival
The final outcome of the patient at 120 days will be registered as a dichotomous variable (0 survived, 1 dead)
Measured: 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
Measured: 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
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220448
- Sponsor's protocol ID
- BD-2024
- Acronym
- BADGUY
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Epidemiology and Burden of Blunt Adrenal Gland Injury in the Context of Major Trauma
- ClinicalTrials.gov ID
- NCT06220448
- Acronym / sponsor ID
- BADGUY / BD-2024
- Conditions
- Trauma, Adrenal Gland Injury
- Keywords
- Trauma, blunt adrenal gland trauma, major trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Jan 2024 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAGI | – | –patients suffering from thoraco-abdominal blunt trauma with and without blunt adrenal gland injury |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients presenting to ED diagnosed with acute appendicitis and eligible for laparoscopic appendectomy
Key inclusion criteria (2 listed)
- Age > 16 years old
- All patients with blunt thoraco-abdominal trauma
Key exclusion criteria (3 listed)
- TBI with AIS > 3
- Isolated TBI and Spinal cord injury
- Patients died in emergency department
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
Injury Severity Score (ISS)
Time frame: 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.
5 secondary outcomes
Presence and number of thoraco-abdominal injuries
Time frame: 120 days
Organ Injury Scale of the blunt adrenal trauma(OIS)
Time frame: 120 days
Overall survival
Time frame: 120 days
Overall length of stay
Time frame: 120 days
Overall length of stay at ICU
Time frame: 120 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 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Laura Benuzzi, MD contact
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 Trauma and Adrenal Gland Injury, run by Niguarda Hospital at 1 site in Italy.
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 2 inclusion and 3 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 16 Apr 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 Italy. 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 Stefano P Cioffi, MD (+3386032519, stefanopiero.cioffi@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury Severity Score (ISS) (time frame: 120 days after trauma). 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 16 Apr 2026.