NCT07411235

Brief Summary

The aim of this study was to investigate the association between injury mechanism, physical examination findings, and laboratory parameters, and the presence of injuries involving multiple computed tomography (CT) regions on whole-body computed tomography (WBCT) in trauma patients under 18 years of age. Additionally, this study sought to develop a clinical risk assessment score to assist emergency medicine specialists in decision-making, with the goal of reducing unnecessary WBCT utilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
407

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

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

October 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 4, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Pediatric Trauma

Outcome Measures

Primary Outcomes (1)

  • Detection of injuries involving more than one anatomical region on whole-body computed tomography

    The primary outcome was defined as the detection of injuries involving more than one anatomical region on whole-body computed tomography (WBCT). Patients were considered to have positive imaging findings if any trauma-related injury was identified on computed tomography. Incidental findings or abnormalities not related to trauma were not considered positive imaging findings.

    At the time of initial whole body computed tomography acquisition during the index emergency department evaluation (baseline / Emergency Department presentation)

Eligibility Criteria

Age0 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study was conducted at one of the two pediatric trauma centers located in a metropolitan area with a population of approximately 5.5 million. The center provides 24-hour coverage by emergency medicine specialists, pediatricians, pediatric surgeons, radiologists, and other trauma-related specialties. The emergency department has an annual visit volume of approximately 500,000 adult and pediatric patients.

You may qualify if:

  • All trauma patients under 18 years of age who presented to the emergency department and underwent whole-body computed tomography (WBCT) based on the decision of the attending emergency medicine specialist at the time of presentation were included in the study

You may not qualify if:

  • Patients with missing data in the hospital information system or those who left the hospital for any reason before completion of the emergency department diagnostic and treatment process were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilket City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (2)

  • Meltzer JA, Stone ME Jr, Reddy SH, Silver EJ. Association of Whole-Body Computed Tomography With Mortality Risk in Children With Blunt Trauma. JAMA Pediatr. 2018 Jun 1;172(6):542-549. doi: 10.1001/jamapediatrics.2018.0109.

    PMID: 29630685BACKGROUND
  • Strahl A, Willemsen JF, Schoof B, Reinshagen K, Frosch KH, Wintges K. The paediatric polytrauma CT-indication (PePCI)-score-Development of a prognostic model to reduce unnecessary CT scans in paediatric trauma patients. Injury. 2024 May;55(5):111494. doi: 10.1016/j.injury.2024.111494. Epub 2024 Mar 11.

    PMID: 38521635BACKGROUND

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 13, 2026

Study Start

October 22, 2022

Primary Completion

June 22, 2023

Study Completion

October 22, 2023

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations