Trauma Clinical Trial
— BADGUYOfficial title:
Exploring the Epidemiology and Burden of Blunt Adrenal Gland Injury in the Context of Major Trauma
NCT number | NCT06220448 |
Other study ID # | BD-2024 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2024 |
Est. completion date | September 30, 2024 |
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
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | September 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | ASST GOM Niguarda | Miano | Lombardy |
Lead Sponsor | Collaborator |
---|---|
Niguarda Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Overall survival | The final outcome of the patient at 120 days will be registered as a dichotomous variable (0 survived, 1 dead) | 120 days | |
Secondary | 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 | |
Secondary | 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 |
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