Trauma InjuryWHOLENCT07411235
Development of WHOLE Score
An observational study of Trauma Injury, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 18 years
- Conditions the study is for
- Trauma Injury
- How many people
- 407 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2022to 22 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Trauma Injury
- Keywords
- Pediatric Trauma
- Medical subject headings
- Accidental Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of initial whole body computed tomography acquisition during the index emergency department evaluation (baseline / Emergency Department presentation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start22 Oct 2022
- Primary completion22 Jun 2023
- Study completion22 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Pamukcu Gunaydin, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411235
- Sponsor's protocol ID
- ASH1
- Acronym
- WHOLE
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29630685Strahl 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.
PubMed 38521635Cay E, Pamukcu Gunaydin G, Yildirim C, Sener A. Development of a novel clinical decision support tool for determining the need for whole-body computed tomography in pediatric trauma patients: the WHOLE score. BMC Emerg Med. 2026 Jun 24. doi: 10.1186/s12873-026-01658-w. Online ahead of print.
PubMed 42343206
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07411235
- Acronym / sponsor ID
- WHOLE / ASH1
- Conditions
- Trauma Injury
- Keywords
- Pediatric Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Oct 2023 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 29630685Meltzer 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.
- Background: PubMed 38521635Strahl 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.
- Derived from this study: PubMed 42343206Cay E, Pamukcu Gunaydin G, Yildirim C, Sener A. Development of a novel clinical decision support tool for determining the need for whole-body computed tomography in pediatric trauma patients: the WHOLE score. BMC Emerg Med. 2026 Jun 24. doi: 10.1186/s12873-026-01658-w. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07411235, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.