TraumaNCT05016986
Penetrating Gunshot Injuries at a Single Johannesburg Centre
An observational study of Trauma, run by University of Witwatersrand, South Africa at 2 sites in South Africa.
Trial summary
A retrospective audit of cardiac penetrating cardiac injuries with specific reference to GSW Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Standard clinical management
- How many people
- 40 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 1 Jan 2008to 30 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Trauma patients who sustained GSW to chest with cardiac injuries in a sigle centre
Who may be able to join
- all adult Priority 1 patients with GSW cardiac injuries seen at a Johannesburg Trauma facility
Who cannot join
- Incomplete data or dead on arrival
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Charlotte Maxeke Johanneburg Academic Hospital
Johannesburg, Gauteng, 2193
Charlotte Maxeke Johanneburg Academic Hospital
Johannesburg, Gautheng, 2193
About this study
Official title: Penetrating Gunshot Cardiac Injuries: Single Centre Experience
A retrospective audit of cardiac penetrating cardiac injuries with specific reference to GSW
Read the detailed description
A descriptive retrospective study looking at the outcomes in patients with penetrating cardiac injuries especially following gunshot injuries. The physiology on presentation, the ISS, the RTS, the clinical injuries confirmed, the type of investigations conducted, the length of hospital stay, the in-hospital mortality will all be collected. Descriptive study statistics will be utilized and a p-value of <0,05 will be considered statistically significant.
- Conditions
- Trauma
- Being tested
- Standard clinical management
- Keywords
- cardiac, penetrating, GSW
- 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.
Standard clinical managementOther
outcomes in GSW cardiac injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury patterns (check list)
Document cardiac injuries noted in the study group
Measured: 01 Jan 2008 till 31 December 2018
The number of in-hospital patients who survive the injury
Measured: 01 jan 2008 till 31 December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Jan 2008
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maeyane Stephens Moeng, University of Witwatersrand, South Africa
- Investigators
- Maeyane Moeng, MBBCH, FCS, Principal investigator, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016986
- Sponsor's protocol ID
- M180550
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penetrating Gunshot Cardiac Injuries: Single Centre Experience
- ClinicalTrials.gov ID
- NCT05016986
- Acronym / sponsor ID
- M180550
- Conditions
- Trauma
- Keywords
- cardiac, penetrating, GSW
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 23 Aug 2021 (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.
A retrospective audit of cardiac penetrating cardiac injuries with specific reference to GSW
Detailed description
A descriptive retrospective study looking at the outcomes in patients with penetrating cardiac injuries especially following gunshot injuries. The physiology on presentation, the ISS, the RTS, the clinical injuries confirmed, the type of investigations conducted, the length of hospital stay, the in-hospital mortality will all be collected. Descriptive study statistics will be utilized and a p-value of <0,05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients who sustained GSW to chest with cardiac injuries in a sigle centre
Key inclusion criteria (1 listed)
- all adult Priority 1 patients with GSW cardiac injuries seen at a Johannesburg Trauma facility
Key exclusion criteria (1 listed)
- Incomplete data or dead on arrival
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 |
|---|---|---|
| Standard clinical managementoutcomes in GSW cardiac injuries | Other | – |
Primary outcome
Injury patterns (check list)
Time frame: 01 Jan 2008 till 31 December 2018
Document cardiac injuries noted in the study group
The number of in-hospital patients who survive the injury
Time frame: 01 jan 2008 till 31 December 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Maeyane Moeng, MBBCH, FCS principal investigator
University of Witwatersrand, South Africa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by University of Witwatersrand, South Africa at 2 sites in South Africa.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury patterns (check list) (time frame: 01 Jan 2008 till 31 December 2018). 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?
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 23 Aug 2021.