- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05224570
Epidemiology of Gunshot Wounds Injuries Admitted in ICU in France (GSW_in_ICU)
Epidemiology of Gunshot Wounds Injuries Admitted in Intensive Care Unit in France: a Retrospective Multicenter Observational Study
In civilian practice, the incidence of firearm violence depends on the country. In high income countries, most cases are reported in the USA or South Africa. In these countries, gunshot wounds (GSW) represent 20% of death cases in trauma centers, more than motor vehicle collisions.
The mortality in civilian practice occurs during the first 24 hours following GSW, mainly due to hemorrhage and traumatic brain injury, though long term effects on physical and psychological outcomes have also been shown.
Some factors of mortality specific to GSW have been established: multiples wounds, homicide vs suicide attempt, impact zone, or firearm caliber.
Few specific guidelines have been published concerning civilian GSW management. These cases are mostly treated in standard guidelines, such as hemorrhagic shock or traumatic brain injury guidelines. As in other trauma mechanisms, the "platinum ten minutes and golden hour" concept is applicable.
In Europe, the incidence of civilian GSW is much lower and few European studies have been published recently. Penetrating injuries in Europe are less likely to be GSW, and are more often self-inflicted than in the USA. In addition, European studies are heterogeneous, due to the difference in populations, healthcare systems and GSW being grouped with stabbing wounds under the label "penetrating trauma".
However, there is a global concern in Europe regarding a potential rise of GSW, with higher severity score than conventional trauma patients and often necessitate ICU admission. Studies analyzing data from different European countries show significantly different ICU admission rates for overall GSW, ranging from 17% up to 30%.
Therefore, the investigators conducted a multicenter, retrospective study on four French University Hospitals aiming to describe the epidemiology (mortality and type of organ damage) and identify prognosis factors of civilian GSW admitted in ICU.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nimes, France, 30029
- CHU de Nimes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Admission for gunshot wound care in ICU between 1st of January 2015 and June 30th 2021 at Nimes University Hospital, Marseille North University Hospital, Montpellier University Hospital, Toulon Military Teaching Hospital.
- Patient ≥ 15 years old
Exclusion Criteria:
- Patient < 15 years old
- Patient who objected to the use of their data.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Gunshot wounds admitted in ICU
patient with Gunshot wounds admitted to ICU
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: day 28
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mortality rate at day 28 of patients admitted for Gunshot wounds
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day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Day 0
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To identify if age is a prognosis factors of mortality of patients admitted for Gunshot
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Day 0
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Sex
Time Frame: Day 0
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To identify if sex is a prognosis factors of mortality of patients admitted for Gunshot
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Day 0
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Comorbidity
Time Frame: Day 0
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To identify if some comorbidities are some prognosis factors of mortality of patients admitted for Gunshot wounds (age, sex, comorbidity, type of gunshot, bullet impact zone, delay to reach hospital, biological parameters at ICU admission, use of antibiotics, blood transfusion, type of surgery, medical management, initiation of renal replacement therapy, length of ICU stay, ).
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Day 0
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Type of gunshot
Time Frame: Day 0
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To identify if the type of gunshot is prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0
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Bullet impact zone
Time Frame: Day 0
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To identify if the impact zone is a prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0
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Delay to reach hospital
Time Frame: Day 0
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To identify if the delay to reach hospital is a prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0
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biological parameters at ICU admission
Time Frame: Day 0
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To identify if some biological parameters at admission are prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0
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antibiotics cure
Time Frame: Day 0
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To identify if an antibiotic cure at admission is a prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0
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Blood transfusion
Time Frame: Day 0 to day 30
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To identify if a blood transfusion is a prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0 to day 30
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Type of surgery
Time Frame: Day 0 to day 30
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To identify if surgery type is a prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0 to day 30
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renal replacement therapy
Time Frame: Day 0 to day 30
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To identify if initiation of renal replacement therapy is a prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0 to day 30
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length of ICU stay
Time Frame: Day 0 to day 30
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To identify if length of ICU stay is a prognosis factors of mortality of patients admitted for Gunshot wounds
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Day 0 to day 30
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Collaborators and Investigators
Investigators
- Principal Investigator: Loic ROUGERIE, CHU Nimes
- Study Director: Laurent MULLER, Md, PhD, CHU Nimes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2021/LR-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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