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临床试验/NCT06930820
NCT06930820招募中不适用

In-Hospital Electronic Registry of Severe Trauma of the Fondazione I.R.C.C.S. Policlinico San Matteo (TRAUMA REGISTRY S. MATTEO)

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2022年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,000
试验地点
1
主要终点
In-hospital mortality rate

研究概览

简要总结

The objective of establishing an in-hospital Trauma Registry, aimed at collecting data on patients who are victims of major trauma and treated at our Center, is to develop a comprehensive and in-depth tool for the analysis and monitoring of clinical activity within a Level I Trauma Center. The purpose of building such databases-specifically the proposed Trauma Registry-is to provide the hospital with a unique instrument for analyzing and monitoring the epidemiology and management of a specific patient population.

In light of recent developments in the hospital's newly implemented clinical care pathway (PDTA) for the management of polytrauma patients, and the strategic enhancement offered by the opening of a dedicated helipad for the reception of such patients, our working group is committed to promoting a tool that may, both in the short and long term, foster clinical and scientific advancement at the Fondazione I.R.C.C.S. Policlinico San Matteo in Pavia.

Our general objective is the prospective collection of data on major trauma patients admitted to and treated at the Fondazione I.R.C.C.S. Policlinico San Matteo.

Our primary objective is to evaluate in-hospital mortality, used as a qualitative indicator of the Trauma Center's performance, among patients with severe trauma managed at our institution.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • All consecutive patients presenting to the Emergency Department of the Fondazione I.R.C.C.S. Policlinico San Matteo who meet at least one of the following criteria will be included in the registry:
  • They were transported to the Emergency Department by Emergency Medical Services (AREU - Regional Emergency and Urgency Agency) with a diagnosis of Severe Trauma / Major Trauma
  • They arrived at the Emergency Department and were admitted with a diagnosis of "trauma", and were found, upon completion of the secondary assessment, to have an Injury Severity Score (ISS) >15

排除标准

  • There are no exclusion criteria.

结局指标

主要结局

In-hospital mortality rate

时间窗: through study completion, an average of 10 years

The primary objective of the registry is to evaluate in-hospital mortality for patients with severe trauma treated at the Fondazione I.R.C.C.S. Policlinico San Matteo.

次要结局

  • Relationship between the severity of traumatic injuries, quantified using the Injury Severity Score (ISS), and in-hospital mortality(through study completion, an average of 10 years)
  • Hospital length of stay and its relationship with the ISS(through study completion, an average of 10 years)
  • Intensive Care Unit (ICU) length of stay and its relationship with the ISS(through study completion, an average of 10 years)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Ansaloni

MD

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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