Plain English Summary
Background and study aims
In the 21st century, the characteristics of wars have changed dramatically. Fighting is no longer limited to the battlefield, and many conflicts now take place in civilian areas. This has in turn led to a significant increase in injuries to members of the public, who are not engaging in the fighting themselves. The use of firearms and explosive devices (high kinetic energy weapons) are being used more and more in modern conflicts, a great deal of which takes place in public places such as city centres. In many cases, the injured are taken to civilian hospitals in their own cars, whereas others are taken by ambulance. The aim of this study is to find out whether there is a difference in recovery and death rates in those taken to hospital by ambulance, and those taken by personal vehicles.
Who can participate?
People who have been injured with a high kinetic energy (fast moving) weapon, e.g. gunshot, mine.
What does the study involve?
After agreeing to take part in the study, patients or their relatives are asked to complete a survey asking for information about how they received their injury, the transport used to take them to hospital and information about their social status. Medical records of participants are also reviewed so that the severity of their injuries can be calculated. The health of participants is then monitored for six months after discharge from hospital.
What are the possible benefits and risks of participating?
A possible benefit of participating in the study is that as participants are monitored so closely, potential complications could be spotted and treated earlier. There are no risks of participating in the study.
Where is the study run from?
1. Hakkari State Hospital (Turkey)
2. Van Training and Research Hospital (Turkey)
3. Dicle University Faculty of Medicine (Turkey)
4. Yuzuncu Yıl University Faculty of Medicine (Turkey)
When is the study starting and how long is it expected to run for?
September 2015 to September 2016
Who is funding the study?
Yuzuncu Yıl University (Turkey)
Who is the main contact?
Miss Cristina Zarauz
Trial website
Contact information
Type
Scientific
Primary contact
Mr Sebahattin Celik
ORCID ID
http://orcid.org/0000-0003-0300-0113
Contact details
Yuzuncu Yil University
Department of General Surgery
Zeve Campus
VAN
65080
Turkey
+90 5057057957
drsebahattincelik@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The Effect of transport modality on high kinetic energy wounded victims' mortality and morbidity
Acronym
Study hypothesis
The aim of this study is to investigate whether the type of transport is important in high kinetic energy injuries for morbidity and mortality.
Ethics approval
Ethical Committee of Yuzuncu Yıl University, 27/10/2015, ref: 01
Study design
Prospective observational multi-centre cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
High kinetic energy weapons (gunshots and mine explosions) victims
Intervention
All victims who have been transported to the hospital by whether ambulance or other vehicles will asked to take a survey which is about details of injury and demographics after their informed constant have obtained. A Glasgow Coma Scale and Injury Severity Score will be calculated base on victims first admission to hospital. Then all patients will be followed until 6 months in regards of complications and mortalities.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. Transport vehicle type will be observed when the patient arrives at hospital and will be confirmed in the survey
2. Injury Severity Score (ISS) will be calculated after the patients have arrived at hospital
3. Short term complications and mortality will be determined throughout the patients' hospitalisation through use of patient notes
4. Long term morbidity and mortality will be determined through monitoring patients for 6 months after discharge from hospital, any mortality or morbidity that is related to the primary injury will be noted
Secondary outcome measures
1. Time period that passed until patient arrived at hospital will be calculated in minutes by subtracting the event time from the hospital arrival time
2. Patient demographic (age and gender) will be determined from the patient or relatives during survey after hospitalisation
3. Type of weapon that caused the injury will be determined from the patient or relatives during survey after hospitalisation
4. Types of treatment required will be derived from patient notes after hospitalisation. Patients are divided into the following subgroups:
4.1. Support therapy: Patients who have been given IV fluid and antibiotics only
4.2. Support plus Blood Transfusion: Transfusion number will be noted
4.3. Surgery therapy: Surgery modality will be noted
Overall trial start date
15/08/2015
Overall trial end date
01/11/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Injured with any kind of high kinetic energy weapon during a conflict
2. Victims whose pre-hospital and post-hospital data is available
3. Patients able to provide informed consent
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients injured by other means (e.g. car accidents, stab wounds)
2. Victims who died before being admitted to hospital
Recruitment start date
01/09/2015
Recruitment end date
01/05/2016
Locations
Countries of recruitment
Turkey
Trial participating centre
Yuzuncu Yıl University Faculty of Medicine
Zeve Campus
VAN
65080
Turkey
Trial participating centre
Dicle University Faculty of Medicine
Dicle Üniversitesi Rektörlüğü
Merkez
Diyarbakır
21100
Turkey
Trial participating centre
Van Military Hospital
Van
65100
Turkey
Trial participating centre
Hakkari State Hospital
Hakkari
301000
Turkey
Sponsor information
Organisation
Yuzuncu Yıl University
Sponsor details
Zeve Campus
VAN
65080
Turkey
+90 432 225 17 0105
scelik@yyu.edu.tr
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Yuzuncu Yıl University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Plan to share the results by publishing an original research article.
Intention to publish date
01/07/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28886492