Penetrating Trauma Registry and Open Source DataNCT06136273
Penetrating Trauma Registry and Open Source Data
An observational study of Penetrating Trauma Registry and Open Source Data, run by Methodist Health System at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Penetrating Trauma Registry and Open Source Data
- What is being tested?
- Treatment measures and intervention strategies
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 19 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Methodist Health System (MHS) trauma patients
Who may be able to join
- • Aged 16 years or older (National Trauma Data Standard for adult)
- Penetrating injury or intent to cause penetrating injury
Who cannot join
- • Aged 15 years or younger
- Prisoners, pregnant persons, or other protected population
- Not involved in penetrating trauma
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Bethany Brauer, MPH, 214-947-4681 ext. 71281, mhsirb@mhd.com
Colette Ngo Ndjom, MS, 217-947-4681, mhsirb@mhd.com
About this study
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.
Read the 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
- Being tested
- Treatment measures and intervention strategies
- Keywords
- Trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment measures and intervention strategiesBehavioural
Also called Injury prevention
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
comprehensive data series
To establish a comprehensive data series from observational data to gain a better understanding of the specifics surrounding penetrating trauma and related events
Measured: 3 years
observational process improvement
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Aug 2023
- Primary completion19 Aug 2025 (estimated)
- Study completion19 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Penetrating Trauma Registry and Open Source DataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136273
- Sponsor's protocol ID
- 106.TRA.2022.D
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 303357903. 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.
PubMed 329030695. 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.
PubMed 250852357. 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 at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penetrating Trauma Registry and Open Source Data
- ClinicalTrials.gov ID
- NCT06136273
- Acronym / sponsor ID
- 106.TRA.2022.D
- Keywords
- Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 19 Aug 2025 (estimated)
- Study completion
- 19 Aug 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Methodist Health System (MHS) trauma patients
Key inclusion criteria (2 listed)
- • Aged 16 years or older (National Trauma Data Standard for adult)
Key exclusion criteria (3 listed)
- • Aged 15 years or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment measures and intervention strategiesAlso: Injury preventionTo 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. | Behavioural | – |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- BackgroundBjelopera, 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.
- Background: PubMed 30335790Lin 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.
- Background3. 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
- Background: PubMed 32903069AJPH Global News. Am J Public Health. 2020 Oct;110(10):1446. doi: 10.2105/AJPH.2020.305872. No abstract available.
- Background5. 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
- Background: PubMed 25085235Shultz 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.
- Background7. 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
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penetrating Trauma Registry and Open Source Data, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comprehensive data series (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136273, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.