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OpenTrials
Completed

NCT Number: NCT07411235

Development of WHOLE Score

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.

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Key information

Age range

0 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilket City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

Whole-body computed tomography (WBCT) is widely used in the initial assessment of pediatric trauma patients to rapidly identify injuries; however, its routine use exposes children to substantial ionizing radiation. Clear guidance on which pediatric trauma patients truly benefit from WBCT is lacking, leading to practice variability and potential overuse in emergency departments.

This study included trauma patients under 18 years of age who underwent WBCT in a tertiary pediatric trauma center . The primary outcome was the presence of traumatic injuries involving two or more anatomical regions on WBCT. Candidate predictors were identified from the literature and clinical practice and evaluated using multivariable logistic regression. Continuous variables were dichotomized based on receiver operating characteristic (ROC) analysis. Independent predictors were used to develop a clinical decision support tool, the WHOLE score. Model performance was assessed using ROC analysis and diagnostic accuracy metrics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Development of a Novel Clinical Decision Support Tool for Determining the Need for Whole-body Computed Tomography in Pediatric Trauma Patients: the WHOLE Score

Acronym: WHOLE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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