- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06136273
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
Status
Recruiting
Intervention / Treatment
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.
Sponsor
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
- Bjelopera, J. (2022). Public Mass Shootings in the United States: Selected Implications for Federal Public Health and Safety Policy. Retrieved 18 August 2022, from https://crsreports.congress.gov/product/pdf/R/R43004.
- Lin PI, Fei L, Barzman D, Hossain M. What have we learned from the time trend of mass shootings in the U.S.? PLoS One. 2018 Oct 18;13(10):e0204722. doi: 10.1371/journal.pone.0204722. eCollection 2018.
- 3. Luca, M., Malhotra, D., & Poliquin, C. (2020). The impact of mass shootings on gun policy. Journal Of Public Economics, 181, 104083. https://doi.org/10.1016/j.jpubeco.2019.104083
- AJPH Global News. Am J Public Health. 2020 Oct;110(10):1446. doi: 10.2105/AJPH.2020.305872. No abstract available.
- 5. Schildkraut, J., Elsass, H., & Meredith, K. (2017). Mass shootings and the media: why all events are not created equal. Journal Of Crime And Justice, 41(3), 223-243. https://doi.org/10.1080/0735648x.2017.1284689
- Shultz JM, Thoresen S, Flynn BW, Muschert GW, Shaw JA, Espinel Z, Walter FG, Gaither JB, Garcia-Barcena Y, O'Keefe K, Cohen AM. Multiple vantage points on the mental health effects of mass shootings. Curr Psychiatry Rep. 2014 Sep;16(9):469. doi: 10.1007/s11920-014-0469-5.
- 7. Silva, J. (2020). A Comparative Analysis of Foiled and Completed Mass Shootings. American Journal Of Criminal Justice, 46(2), 187-208. https://doi.org/10.1007/s12103-020-09552-2
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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