Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:40 AM
Study NCT ID:
NCT07411235
Status:
COMPLETED
Last Update Posted:
2026-02-13
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of WHOLE Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2023-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of injuries involving more than one anatomical region on whole-body computed tomography', 'timeFrame': 'At the time of initial whole body computed tomography acquisition during the index emergency department evaluation (baseline / Emergency Department presentation)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Trauma'], 'conditions': ['Trauma Injury']}, 'referencesModule': {'references': [{'pmid': '29630685', 'type': 'BACKGROUND', 'citation': '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': '38521635', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT07411235', 'acronym': 'WHOLE', 'briefTitle': 'Development of WHOLE Score', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Development of a Novel Clinical Decision Support Tool for Determining the Need for Whole-body Computed Tomography in Pediatric Trauma Patients: the WHOLE Score', 'orgStudyIdInfo': {'id': 'ASH1'}}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilket City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asisstant Professor', 'investigatorFullName': 'Gul Pamukcu Gunaydin', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}