The role of ambulances in morbidity and mortality of gunshot injuries

ISRCTN ISRCTN49138604
DOI https://doi.org/10.1186/ISRCTN49138604
Secondary identifying numbers N/A
Submission date
08/09/2015
Registration date
15/10/2015
Last edited
06/11/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Sebahattin Celik
Scientific

Yuzuncu Yil University
Department of General Surgery
Zeve Campus
VAN
65080
Türkiye

ORCiD logoORCID ID 0000-0003-0300-0113
Phone +90 5057057957
Email drsebahattincelik@hotmail.com

Study information

Study designProspective observational multi-centre cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleThe Effect of transport modality on high kinetic energy wounded victims' mortality and morbidity
Study objectivesThe 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(s)Ethical Committee of Yuzuncu Yıl University, 27/10/2015, ref: 01
Health condition(s) or problem(s) studiedHigh kinetic energy weapons (gunshots and mine explosions) victims
InterventionAll 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 typeSupplement
Primary outcome measure1. 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 measures1. 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 study start date15/08/2015
Completion date01/11/2016

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participants100
Key inclusion criteria1. 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
Key exclusion criteria1. Patients injured by other means (e.g. car accidents, stab wounds)
2. Victims who died before being admitted to hospital
Date of first enrolment01/09/2015
Date of final enrolment01/05/2016

Locations

Countries of recruitment

  • Türkiye

Study participating centres

Yuzuncu Yıl University Faculty of Medicine
Zeve Campus
VAN
65080
Türkiye
Dicle University Faculty of Medicine
Dicle Üniversitesi Rektörlüğü
Merkez
Diyarbakır
21100
Türkiye
Van Military Hospital
Van
65100
Türkiye
Hakkari State Hospital
Hakkari
301000
Türkiye

Sponsor information

Yuzuncu Yıl University
University/education

Zeve Campus
VAN
65080
Türkiye

Phone +90 432 225 17 0105
Email scelik@yyu.edu.tr
ROR logo "ROR" https://ror.org/041jyzp61

Funders

Funder type

University/education

Yuzuncu Yıl University

No information available

Results and Publications

Intention to publish date01/07/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlan to share the results by publishing an original research article.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2017 Yes No

Editorial Notes

06/11/2017: Publication reference has been added.
24/03/2016: Ethics approval information added. In addition, the overall trial end date has been updated from 01/01/2017 to 01/11/2016 and the recruitment end date has been updated from 01/09/2016 to 01/05/2016.