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临床试验/NCT07819279
NCT07819279尚未招募不适用

Development and Validation of FOUR Score-Modified Trauma Scoring Systems for Mortality Prediction in Trauma Patients: A Multicenter Prospective Observational Cohort Study

Al-Nahrain University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,000
试验地点
1
主要终点
In hospital mortality

研究概览

简要总结

The goal of this multicenter prospective observational cohort study is to develop and validate FOUR Score-modified trauma scoring systems for mortality prediction in adult trauma patients. The main question it aims to answer is (1) do FOUR Score-modified versions of the Revised Trauma Score (RTS), Trauma and Injury Severity Score (TRISS), New Trauma Score (NTS), and Glasgow Coma Scale, Age, and Systolic Blood Pressure (GAP) Score improve mortality prediction compared with their corresponding original scores? Researchers will compare the original scoring systems with their corresponding FOUR Score-modified versions to assess differences in discrimination and overall predictive performance. Participants will undergo routine clinical assessment, including assessment of the Glasgow Coma Scale and Full Outline of UnResponsiveness Score, and relevant demographic, physiological, and injury-related data will be prospectively recorded; no experimental intervention will be administered.

详细描述

Trauma is the leading cause of death worldwide, particularly in those younger than 35 years of age. Injuries and violence represent a major global public health, according to the World Health Organization (WHO), injuries and violence cause approximately 4.4 million deaths worldwide each year, accounting for nearly 8% of all deaths. Of these, about 3.16 million deaths are attributable to unintentional injuries and 1.25 million to violence-related injuries. Injuries and violence also contribute substantially to disability, with an estimated 10% of all years lived with disability attributed to these conditions.

Trauma severity scoring systems are important adjuncts to trauma care and are used to characterize the nature and extent of injury. They can support triage and assist in assessing and predicting patient outcomes, thereby helping to organize and improve trauma care systems. Trauma scoring systems can be divided into anatomical, physiological, and combined scores each with advantages and disadvantages. Anatomical scores describe the injuries recorded by clinical examination, imaging, surgery, or autopsy. While Physiologic Scores describe changes due to a trauma and translated by changes in vital signs and consciousness. The combination of anatomic scoring system and physiological scoring system is better than single scoring system for death prediction in patients with severe trauma in ICU, and it may be considered to be a new method for early identification of death risk in patients with severe trauma.

The Revised Trauma Score (RTS), a revision of the original Trauma Score developed by Champion et al., in 198, is a commonly used prehospital trauma triage tool. While there has been conceptual evolution of the core concept behind the RTS since its development, including the development of respiratory rate, pulse rate, and motor response (RPM) measure by Sacco et al., which may provide important mitigation of subjectivity of Glasgow Coma Scale (GCS) assessment, the RTS remains most prevalent in the literature. The RTS only requires three metrics to calculate: respiratory rate, systolic blood pressure, and GCS.

First introduced by Champion et al. in 1981, TRISS is a combination of the RTS and ISS with an age component. This system was to assess patients at the time of initial presentation to predict overall prognosis. Earlier studies had issues related to its applicability, but recent studies lend support to TRISS being a better scoring system when compared with others, such as ISS, NISS, and RTS. The past three decades have seen many international studies providing evidentiary support that it is, in fact, an accurate predictor of patient mortality.

More recent scoring systems, such as the Glasgow Coma Scale, Age, and Systolic Blood Pressure (GAP) score, have gained attention due to their simplicity and applicability in the field. The GAP score is especially relevant for traffic accident triage, as it can be quickly implemented at the scene, allowing for more efficient patient stratification and resource allocation. The New Trauma Score (NTS), which replaces the Respiratory Rate (RR) with arterial blood oxygen saturation percentage (SpO2), has shown improved performance over RTS in predicting mortality for trauma patients, including those from traffic accidents.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with sufficient clinical data to calculate the fREMS score, including the FOUR Score and other required physiological variables.
  • Patients with a documented mortality outcome .

排除标准

  • Patients transferred from another hospital after initial resuscitation.
  • Patients who died before the required initial clinical assessment

结局指标

主要结局

In hospital mortality

时间窗: In-Hospital Phase (average of 10 days through discharge)

Mortality (death) during hospitalization

次要结局

未报告次要终点

研究者

发起方
Al-Nahrain University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulillah R. Khamees

College Of Medicine - Nahrain University

Al-Nahrain University

研究点 (1)

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