Comparison of the BIG Score and the Pediatric Trauma Score

Официальное название

Comparison of the BIG Score and the Pediatric Trauma Score in Predicting Mortality Among Pediatric Trauma Patients.

Обзор

The goal of this observational study is to evaluate and compare the predictive performance of the BIG Score and the Pediatric Trauma Score (PTS) in predicting mortality among pediatric trauma patients presenting to the emergency department. The main questions it aims to answer are: Does the BIG Score accurately predict mortality in pediatric trauma patients? Is the Pediatric Trauma Score (PTS) effective in predicting mortality among pediatric trauma patients? Which scoring system demonstrates better sensitivity, specificity, and overall predictive accuracy for mortality? Researchers will compare the BIG Score with the Pediatric Trauma Score to determine which scoring system provides superior prognostic value in pediatric trauma cases. Participants will: Undergo routine clinical assessment upon admission to the emergency department. Have vital signs, Glasgow Coma Scale (GCS), and trauma-related clinical parameters recorded. Undergo laboratory investigations including Base Deficit and International Normalized Ratio (INR). Be followed during hospitalization to assess outcomes, including survival or mortality.

Подробное описание

This study focuses on assessing the clinical usefulness of two pediatric trauma scoring systems in emergency settings and determining their role in early prognostic evaluation after traumatic injury. Accurate prediction of patient outcomes during the initial hours of admission is essential for prioritizing management decisions, optimizing intensive care utilization, and improving overall quality of trauma care.

The BIG Score incorporates biochemical and neurological indicators that reflect the physiological impact of trauma, while the Pediatric Trauma Score relies mainly on bedside clinical findings obtained during the primary assessment. Evaluating the performance of these tools in real clinical practice may help identify the most practical and reliable method for risk stratification among injured children.

Data collection will include demographic characteristics, type and mechanism of trauma, hemodynamic status at presentation, neurological findings, and relevant laboratory parameters obtained during the initial emergency evaluation. Both scores will be calculated for each patient shortly after admission and analyzed in relation to clinical outcomes observed during hospitalization.

The study will also explore the association between trauma severity scores and the need for advanced supportive measures such as intensive care admission, ventilatory support, blood product administration, and prolonged hospitalization. Statistical analysis will be performed to determine the prognostic performance and clinical applicability of each scoring system in pediatric trauma assessment.

Вмешательства

• Диагностический тест blood sampling
  Pediatric trauma patients presenting to the emergency department will undergo routine clinical and laboratory evaluation according to institutional trauma management protocols. Upon admission, physiological and laboratory parameters required for calculation of the BIG Score and the Pediatric Trauma Score (PTS) will be collected. The BIG Score will be determined using Base Deficit, International Normalized Ratio (INR), and Glasgow Coma Scale (GCS), while the Pediatric Trauma Score will be calcul

Первичные конечные точки

• In-hospital mortality among pediatric trauma patients. [Срок оценки: From admission to discharge (up to 30 days)]

Вторичные конечные точки (2)

• ICU admission among pediatric trauma patients. [Срок оценки: From admission to discharge (up to 30 days)]
• Emergency surgical intervention among pediatric trauma patients [Срок оценки: From admission to discharge (up to 30 days)]

Критерии участия

Критерии включения

• Pediatric trauma patients from birth up to 16 years of age.
• Presentation to the Emergency Department within 24 hours of the primary injury.

Критерии исключения

• Patients with minor traumas who are treated and discharged directly from the ED.
• Patients initially managed at and referred from another hospital.
• Patients whose legal guardians discharge them against medical advice (AMA) before outcome data can be ascertained.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Az A, Dogan Y, Sogut O, Akdemir T. Comparison of the BIG Score and Pediatric Trauma Score for Predicting Mortality. Pediatr Emerg Care. 2024 Dec 1;40(12):839-843. doi: 10.1097/PEC.0000000000003267. Epub 2024 Aug 27. PMID 39190391
• Schuster A, Klute L, Kerschbaum M, Kunkel J, Schaible J, Straub J, Weber J, Alt V, Popp D. Injury Pattern and Current Early Clinical Care of Pediatric Polytrauma Comparing Different Age Groups in a Level I Trauma Center. J Clin Med. 2024 Jan 22;13(2):639. doi: 10.3390/jcm13020639. PMID 38276145

Идентификаторы

NCT: NCT07624955 · Soh-Med-26-5-1MS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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