Whole Body Computed Tomography ImagingNCT06729528
Diagnostic Value of Whole-Body Computed Tomography (WBCT) Scores in Pediatric Trauma Patients
An observational study of Whole Body Computed Tomography Imaging, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Whole Body Computed Tomography Imaging
- What is being tested?
- The PePCI and ManTIS scores
- How many people
- 684 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2024to 30 Oct 2025
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population includes all pediatric trauma cases that present to the red area of the emergency department.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul
About this study
Official title: Diagnostic Value of PePCI and ManTIS Scores in Whole-Body Computed Tomography (WBCT) Decision-Making for Pediatric Trauma Patients in the Emergency Department
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.
Read the detailed description
The assessment of trauma in children is challenging due to difficulties in obtaining information about the mechanism and process of trauma, which leads doctors to perform more imaging. Although the incidence of fatal injuries in children has decreased in the last decade, trauma-related injuries remain a leading cause of death among children over one-year-old. Due to the lower imaging threshold in children compared to adults, whole-body computed tomography (WBCT) is frequently used. WBCT is an essential tool for the rapid diagnosis of injuries, especially in hemodynamically unstable pediatric multi-trauma patients.
The most accurate criteria for activating the trauma team in pediatric trauma patients are still being debated. According to the Advanced Trauma Life Support (ATLS) guidelines, the trauma team is activated based on the mechanism of injury; thus, WBCT is performed even in hemodynamically stable pediatric patients. This situation leads to unnecessary radiation exposure, increased costs, and resource wastage. Although the mechanism of injury does not constitute a sufficient indication for WBCT in pediatric patients, many trauma patients are evaluated with WBCT to avoid missing potential injuries.
In pediatric emergency department patients, it is known that WBCT is not associated with a reduction in mortality but is linked to high radiation exposure and increased lifetime risk for leukemia, solid cancers, and brain tumors. Therefore, although we know the benefits of targeted emergency CT scans, the usefulness of WBCT imaging for pediatric trauma patients is debated.
The severity of injuries, especially in multi-trauma patients, is classified using the Injury Severity Score (ISS). The ISS is based on an anatomical ordinal scale ranging from 1 to 75 points, with low scores representing mild injuries and high scores representing severe and fatal injuries. Generally, an ISS >15 indicates serious injuries. This scoring system is also applicable to children and adolescents. However, pediatric patients show lower mortality for the same ISS compared to adults, attributed to physiological response differences between adults and children. Therefore, a new classification for injury severity in pediatric patients has been proposed. While an ISS >15 in adults indicates serious injury, an ISS >23 in the pediatric population indicates serious injury, and patients with an ISS >26 may have functional impairments at discharge.
To reduce unnecessary radiation exposure and prevent resource wastage in pediatric trauma patients, a new study was conducted by Strahl and colleagues. The study involved pediatric emergency patients with high-energy trauma mechanisms at a Level I trauma center in Germany. As a result of this study, a pediatric polytrauma CT indication score (PePCI) was developed to analyze pediatric trauma patients and reduce radiation exposure. The performance of this score was compared with the ISS. In this study, cases were screened retrospectively. It was found that WBCT was applied to 243 pediatric trauma patients. If the PePCI score had been applied to pediatric trauma patients, it could have been determined that WBCT would not have been necessary for 76 of the 243 patients they screened. Moreover, no significant injuries would have been overlooked.
Another single-center study conducted by Davies and colleagues in the United Kingdom (UK) demonstrated that a large patient group in the UK is exposed to unnecessary radiation. This situation is thought to increase the risk of life-threatening outcomes, such as malignancy, in the future. With appropriate evaluation, it has been shown that WBCT imaging may not be necessary for some trauma patients. A scoring system called the Manchester Trauma Imaging Score (ManTIS) has been developed to facilitate this evaluation. The ManTIS score has been shown to safely reduce the number of unnecessary WBCTs in the young patient group.
Although these studies have shown that the PePCI and ManTIS scores effectively predict the need for WBCT and prevent unnecessary scans, they have been conducted in a single region. The developed scoring systems are only applicable to specific geographical areas. Additionally, both studies were retrospective. Therefore, this study plans to prospectively evaluate the reliability, applicability, and practicality of these scores in clinical practice in Türkiye, assessing their real-life benefits.
- Conditions
- Whole Body Computed Tomography Imaging
- Being tested
- The PePCI and ManTIS scores
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PePCI and ManTIS scoresDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic pediatric patients | Patients under 18 years old present to the emergency department red area due to trauma. Receives: Diagnostic Test: The PePCI and ManTIS scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start13 Nov 2024
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Whole Body Computed Tomography ImagingStudies 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
- Prospective
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Kudu, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729528
- Sponsor's protocol ID
- 09.2024.782
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38521635Davies 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.
PubMed 26377772
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of PePCI and ManTIS Scores in Whole-Body Computed Tomography (WBCT) Decision-Making for Pediatric Trauma Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT06729528
- Acronym / sponsor ID
- 09.2024.782
- Conditions
- Whole Body Computed Tomography Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 11 Dec 2024 (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.
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.
Detailed description
The assessment of trauma in children is challenging due to difficulties in obtaining information about the mechanism and process of trauma, which leads doctors to perform more imaging. Although the incidence of fatal injuries in children has decreased in the last decade, trauma-related injuries remain a leading cause of death among children over one-year-old. Due to the lower imaging threshold in children compared to adults, whole-body computed tomography (WBCT) is frequently used. WBCT is an essential tool for the rapid diagnosis of injuries, especially in hemodynamically unstable pediatric multi-trauma patients.
The most accurate criteria for activating the trauma team in pediatric trauma patients are still being debated. According to the Advanced Trauma Life Support (ATLS) guidelines, the trauma team is activated based on the mechanism of injury; thus, WBCT is performed even in hemodynamically stable pediatric patients. This situation leads to unnecessary radiation exposure, increased costs, and resource wastage. Although the mechanism of injury does not constitute a sufficient indication for WBCT in pediatric patients, many trauma patients are evaluated with WBCT to avoid missing potential injuries.
In pediatric emergency department patients, it is known that WBCT is not associated with a reduction in mortality but is linked to high radiation exposure and increased lifetime risk for leukemia, solid cancers, and brain tumors. Therefore, although we know the benefits of targeted emergency CT scans, the usefulness of WBCT imaging for pediatric trauma patients is debated.
The severity of injuries, especially in multi-trauma patients, is classified using the Injury Severity Score (ISS). The ISS is based on an anatomical ordinal scale ranging from 1 to 75 points, with low scores representing mild injuries and high scores representing severe and fatal injuries. Generally, an ISS >15 indicates serious injuries. This scoring system is also applicable to children and adolescents. However, pediatric patients show lower mortality for the same ISS compared to adults, attributed to physiological response differences between adults and children. Therefore, a new classification for injury severity in pediatric patients has been proposed. While an ISS >15 in adults indicates serious injury, an ISS >23 in the pediatric population indicates serious injury, and patients with an ISS >26 may have functional impairments at discharge.
To reduce unnecessary radiation exposure and prevent resource wastage in pediatric trauma patients, a new study was conducted by Strahl and colleagues. The study involved pediatric emergency patients with high-energy trauma mechanisms at a Level I trauma center in Germany. As a result of this study, a pediatric polytrauma CT indication score (PePCI) was developed to analyze pediatric trauma patients and reduce radiation exposure. The performance of this score was compared with the ISS. In this study, cases were screened retrospectively. It was found that WBCT was applied to 243 pediatric trauma patients. If the PePCI score had been applied to pediatric trauma patients, it could have been determined that WBCT would not have been necessary for 76 of the 243 patients they screened. Moreover, no significant injuries would have been overlooked.
Another single-center study conducted by Davies and colleagues in the United Kingdom (UK) demonstrated that a large patient group in the UK is exposed to unnecessary radiation. This situation is thought to increase the risk of life-threatening outcomes, such as malignancy, in the future. With appropriate evaluation, it has been shown that WBCT imaging may not be necessary for some trauma patients. A scoring system called the Manchester Trauma Imaging Score (ManTIS) has been developed to facilitate this evaluation. The ManTIS score has been shown to safely reduce the number of unnecessary WBCTs in the young patient group.
Although these studies have shown that the PePCI and ManTIS scores effectively predict the need for WBCT and prevent unnecessary scans, they have been conducted in a single region. The developed scoring systems are only applicable to specific geographical areas. Additionally, both studies were retrospective. Therefore, this study plans to prospectively evaluate the reliability, applicability, and practicality of these scores in clinical practice in Türkiye, assessing their real-life benefits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic pediatric patients | – | Diagnostic Test: The PePCI and ManTIS scoresPatients under 18 years old present to the emergency department red area due to trauma. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population includes all pediatric trauma cases that present to the red area of the emergency department.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The PePCI and ManTIS scoresThe 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. | Diagnostic test | Traumatic pediatric patients |
Primary outcome
Whole Body Computed Tomography Need
Time frame: through study completion, an average of 8 months
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.
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 7 Jan 2026.
- 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.
- Background: PubMed 26377772Davies 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.
- 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 Whole Body Computed Tomography Imaging, run by Marmara University Pendik Training and Research Hospital 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 2 inclusion and 4 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 7 Jan 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?
Whole Body Computed Tomography Need (time frame: through study completion, an average of 8 months). 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 NCT06729528, which also lists 2 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 7 Jan 2026.