Condition category
Injury, Occupational Diseases, Poisoning
Date applied
08/09/2015
Date assigned
15/10/2015
Last edited
24/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.