Penetrating Trauma Registry and Open Source Data

November 14, 2023 updated by: Methodist Health System
Penetrating injuries comprise roughly 30% of Methodist Health System (MHS) trauma patients. Firearm-related events have become more prevalent in the past few years. Active shooter events, mass casualties, assaults, and homicide are more commonplace which leads to an increase of trauma patients needing management of penetrating injuries.

Study Overview

Detailed Description

Penetrating injuries comprise roughly 30% of Methodist Health System (MHS) trauma patients. Firearm-related events have become more prevalent in the past few years . Active shooter events, mass casualties, assaults, and homicide are more commonplace which leads to an increase of trauma patients needing management of penetrating injuries. On average, penetrating traumas only make up 14% of comparable center patient volumes. In spring 2022, we also were ranked 3/10 for our penetrating trauma outcomes with lower than expected mortality (TQIP Benchmarking Report). Together, as a Level 1 trauma center with above average penetrating injury volume we must take efforts to best understand the opportunities for our patients and disseminate those observations to the trauma community

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Methodist Dallas Medical Center
        • Contact:
          • Colette Ngo Ndjom, MS
          • Phone Number: 217-947-4681
          • Email: mhsirb@mhd.com
        • Contact:
          • Bethany Brauer, MPH
          • Phone Number: 71281 214-947-4681
          • Email: mhsirb@mhd.com
        • Principal Investigator:
          • Joseph Amos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Methodist Health System (MHS) trauma patients

Description

Inclusion Criteria:

  • • Aged 16 years or older (National Trauma Data Standard for adult)

    • Penetrating injury or intent to cause penetrating injury

Exclusion Criteria:

  • • Aged 15 years or younger

    • Prisoners, pregnant persons, or other protected population
    • Not involved in penetrating trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comprehensive data series
Time Frame: 3 years
To establish a comprehensive data series from observational data to gain a better understanding of the specifics surrounding penetrating trauma and related events
3 years
observational process improvement
Time Frame: 3 years
To conduct observational process improvement and hypothesis-deriving studies related to penetrating traumatic injuries using data from the Methodist trauma registry and open source data repositories.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Estimated)

August 19, 2025

Study Completion (Estimated)

August 19, 2025

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106.TRA.2022.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.

IPD Sharing Time Frame

2 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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