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Blunt ADrenal Gland injUrY (BAD GUY) Project

ConditionsTraumaAdrenal Gland Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-99
SponsorNiguarda Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 16 years old

All patients with blunt thoraco-abdominal trauma

Disqualifiers

TBI with AIS > 3

Isolated TBI and Spinal cord injury

Patients died in emergency department

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 1 trial group
Group A: BAGI

Trial outcomes

Primary outcomes

1

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.

Time frame
120 days after trauma

Secondary outcomes

1

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)

Time frame
120 days
2

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

Time frame
120 days
3

Overall survival

The final outcome of the patient at 120 days will be registered as a dichotomous variable (0 survived, 1 dead)

Time frame
120 days
4

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

Time frame
120 days

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

ASST GOM NiguardaRecruiting20162, Miano, LombardyItalyItaly

Sponsors and contacts

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Niguarda Hospital

Lead sponsor

Source ClinicalTrials.gov
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