Clinical trial NCT06930820: In-Hospital Electronic Registry of Severe Trauma of the Fondazione I.R.C.C.S. Policlinico San Matteo
Official title: In-Hospital Electronic Registry of Severe Trauma of the Fondazione I.R.C.C.S. Policlinico San Matteo (TRAUMA REGISTRY S. MATTEO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients Who Are Victims of Major Trauma
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are victims of major trauma

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: In-hospital mortality rate
timeFrame: through study completion, an average of 10 years
Secondary outcomes:
measure: Relationship between the severity of traumatic injuries, quantified using the Injury Severity Score (ISS), and in-hospital mortality
timeFrame: through study completion, an average of 10 years
measure: Hospital length of stay and its relationship with the ISS
timeFrame: through study completion, an average of 10 years
measure: Intensive Care Unit (ICU) length of stay and its relationship with the ISS
timeFrame: through study completion, an average of 10 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
Study officials:
References: