NCT06220448

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Jan 2024Sep 2027

Study Start

First participant enrolled

January 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

January 11, 2024

Last Update Submit

April 13, 2026

Conditions

Keywords

Traumablunt adrenal gland traumamajor trauma

Outcome Measures

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.

    120 days after trauma

Secondary Outcomes (5)

  • Presence and number of thoraco-abdominal injuries

    120 days

  • Organ Injury Scale of the blunt adrenal trauma(OIS)

    120 days

  • Overall survival

    120 days

  • Overall length of stay

    120 days

  • Overall length of stay at ICU

    120 days

Study Arms (1)

BAGI

patients suffering from thoraco-abdominal blunt trauma with and without blunt adrenal gland injury

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST GOM Niguarda

Miano, Lombardy, 20162, Italy

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Laura Benuzzi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 24, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations