Diagnostic Value of Whole-Body Computed Tomography (WBCT) Scores in Pediatric Trauma Patients

NCT06729528 | Completed

• 1 other identifier: 09.2024.782
• Study Type: observational
• Target: 684
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric trauma assessment is challenging due to difficulties in obtaining information, which increases the need for unnecessary imaging. Trauma-related injuries remain a significant cause of death in children. Although whole-body computed tomography (CT) is frequently used due to a lower threshold for imaging, issues such as high radiation exposure arise. To reduce unnecessary radiation exposure in pediatric trauma patients, scoring systems such as PePCI (Pediatric Polytrauma CT Indication Score) and ManTIS (Manchester Trauma Imaging Score) have been developed. These studies have demonstrated their effectiveness in predicting the need for CT scans and preventing unnecessary examinations. However, both studies are retrospective analyses limited to a single region. Therefore, a prospective study is planned in Türkiye to evaluate the reliability and applicability of these scoring systems and their real-world benefits.

Conditions

Whole Body Computed Tomography Imaging

Outcome Measures

Primary Outcomes (1)

• Whole Body Computed Tomography Need

  Patients will be evaluated by an expert panel, which will include three emergency medicine specialists. The panel will assess all relevant clinical data, including trauma history, physical examination findings, laboratory results, imaging outcomes, consultations, and final dispositions. Based on this comprehensive evaluation, the panel will determine whether the patient requires WBCT. As a result, the primary outcome will be recorded as a binary measure: either the patient requires WBCT or does not require WBCT.

  through study completion, an average of 8 months

Study Arms (1)

Traumatic pediatric patients

Patients under 18 years old present to the emergency department red area due to trauma.

Diagnostic Test: The PePCI and ManTIS scores

Interventions

The PePCI and ManTIS scores DIAGNOSTIC_TEST

The PePCI and ManTIS scores have been developed to predict the indication for whole-body CT in pediatric cases presenting to the emergency department with trauma. These scores help reduce unnecessary radiation exposure in pediatric trauma cases.

Traumatic pediatric patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all pediatric trauma cases that present to the red area of the emergency department.

You may qualify if:

• All pediatric trauma patients who present to the emergency red zone or are deemed appropriate for monitoring in the red zone during their emergency department visit.
• Patients for whom consent to participate in the study is provided by their legal guardians (as children are not able to provide consent independently)

You may not qualify if:

• Patients who have previously been included in the study.
• Patients who refuse treatment before their assessment is completed or withdraw their consent to participate in the study.
• Patients with incomplete study data.
• Patients with penetrating injuries

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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: 38521635 BACKGROUND

• Davies RM, Scrimshire AB, Sweetman L, Anderton MJ, Holt EM. A decision tool for whole-body CT in major trauma that safely reduces unnecessary scanning and associated radiation risks: An initial exploratory analysis. Injury. 2016 Jan;47(1):43-9. doi: 10.1016/j.injury.2015.08.036. Epub 2015 Sep 1.

  PMID: 26377772 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 11, 2024
• Study Start: November 13, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)