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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05224570
Other study ID # LOCAL/2021/LR-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date June 30, 2021

Study information

Verified date January 2022
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU de NIMES Nimes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality mortality rate at day 28 of patients admitted for Gunshot wounds day 28
Secondary Age To identify if age is a prognosis factors of mortality of patients admitted for Gunshot Day 0
Secondary Sex To identify if sex is a prognosis factors of mortality of patients admitted for Gunshot Day 0
Secondary Comorbidity 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, ). Day 0
Secondary Type of gunshot To identify if the type of gunshot is prognosis factors of mortality of patients admitted for Gunshot wounds Day 0
Secondary Bullet impact zone To identify if the impact zone is a prognosis factors of mortality of patients admitted for Gunshot wounds Day 0
Secondary Delay to reach hospital To identify if the delay to reach hospital is a prognosis factors of mortality of patients admitted for Gunshot wounds Day 0
Secondary biological parameters at ICU admission To identify if some biological parameters at admission are prognosis factors of mortality of patients admitted for Gunshot wounds Day 0
Secondary antibiotics cure To identify if an antibiotic cure at admission is a prognosis factors of mortality of patients admitted for Gunshot wounds Day 0
Secondary Blood transfusion To identify if a blood transfusion is a prognosis factors of mortality of patients admitted for Gunshot wounds Day 0 to day 30
Secondary Type of surgery To identify if surgery type is a prognosis factors of mortality of patients admitted for Gunshot wounds Day 0 to day 30
Secondary renal replacement therapy To identify if initiation of renal replacement therapy is a prognosis factors of mortality of patients admitted for Gunshot wounds Day 0 to day 30
Secondary length of ICU stay To identify if length of ICU stay is a prognosis factors of mortality of patients admitted for Gunshot wounds Day 0 to day 30
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