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NCT Number: NCT06930820

In-Hospital Electronic Registry of Severe Trauma of the Fondazione I.R.C.C.S. Policlinico San 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Luca Ansaloni, MD

CONTACT

[email protected]

+39 0382 502490

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. In-hospital mortality rate

    Time frame: 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.

Secondary outcomes

  1. Relationship between the severity of traumatic injuries, quantified using the Injury Severity Score (ISS), and in-hospital mortality

    Time frame: through study completion, an average of 10 years

    Evaluation of the relationship between the severity of traumatic injuries, quantified using the Injury Severity Score (ISS), and in-hospital mortality.

  2. Hospital length of stay and its relationship with the ISS

    Time frame: through study completion, an average of 10 years

    Evaluation of hospital length of stay and its relationship with the ISS.

  3. Intensive Care Unit (ICU) length of stay and its relationship with the ISS

    Time frame: through study completion, an average of 10 years

    Evaluation of Intensive Care Unit (ICU) length of stay and its relationship with the ISS.

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Ansaloni, MD

CONTACT

[email protected]

+39 0382 502490

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Acronym: STRAP register

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.