NCT06750822

Brief Summary

The goal of this retrospective observational study is to evaluate the diagnostic accuracy of pulmonary contusion volume in predicting early pneumonia in patients with thoracic trauma. The primary question we aim to answer is: What is the diagnostic accuracy of pulmonary contusion volume in predicting pneumonia within 7 days post-trauma? Moreover, we aim to explore which is the overlap between the contused segments and those developing pneumonia. Finally, we aim to explore relevant differences in radiomic features between contused segments that developed pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
486

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 20, 2024

Last Update Submit

December 26, 2024

Conditions

Keywords

AASTAISThoraxPneumoniatrauma

Outcome Measures

Primary Outcomes (1)

  • 7d-pneumonia

    Pneumonia appearing within 7 days from trauma, defined as: • New or worsening pulmonary infiltrates plus ≥ 2 of the following: * Body temperature ≥ 38°C or ≤ 35°C * White Blood Cell (WBC) count \> 12,000 or \< 4,000 cells/mL or presence of immature granulocytes in the blood sample * Purulent sputum * Worsening pulmonary oxygenation, defined as a decline in the PaO2/FiO2 ratio

    7 days

Study Arms (1)

Trauma patients

Any patient admitted for trauma in the Emergency Department receiving a whole-body contrast CT scan.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study includes all the consecutive patients admitted to the ED of the institution for trauma and having a contrast whole-body CT scan performed within 6 hours from admission

You may qualify if:

  • Admission to the ED for trauma as primary diagnosis
  • Whole-body contrast CT scan performed within 6 hours from admission

You may not qualify if:

  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maggiore Hospital Carlo Alberto Pizzardi

Bologna, BO, 40128, Italy

Location

Related Publications (1)

  • Gamberini L, Astuti GM, Biavati B, Boarato D, Tontodonati M, Palmitessa I, Laruccia M, Coniglio C, Bertini A, Orlandi PE, Tartaglione M, Allegri D, Bruno A. Pulmonary contusion volume and radiomics as predictors of early-onset pneumonia in trauma patients, a retrospective single-centre study. Eur J Trauma Emerg Surg. 2025 Aug 22;51(1):275. doi: 10.1007/s00068-025-02952-1.

MeSH Terms

Conditions

PneumoniaWounds and Injuries

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

May 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Anonymized data will be shared upon reasonable request

Locations