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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patients Who Are Victims of Major Trauma

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Luca Ansaloni, MD; Phone Number: +39 0382 502490; Email: l.ansaloni@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo di Pavia
    • Contact: Luca Ansaloni, MD; Phone Number: +39 0382 502490; Email: l.ansaloni@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are victims of major trauma

Description

Inclusion Criteria:

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

or

- 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

Exclusion Criteria:

There are no exclusion criteria.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality rate	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.	through study completion, an average of 10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): July 7, 2032
• Study Completion (Estimated): July 7, 2032

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: S.Matteo TRAuma Pavia Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No