- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03358758
Retrospective Morbidity and Mortality Study of Conflict-Related Injuries: Erbil, Iraq
Study Overview
Status
Detailed Description
Trauma is a major cause of morbidity and mortality worldwide. An analysis of the Global Burden of Disease study indicated that in 2013, globally 973 million traumatic injuries warranted medical intervention, while 4.8 million injuries were fatal. The Small Arms Survey - Global Burden of Armed Violence report compiles worldwide conflict-related data and indicates that between 2007-2012, there were a total of 508,000 fatalities attributable to interpersonal violence worldwide, of which 70,000 were conflict-related. Since the U.S. invasion of Iraq in 2003, the country has perpetually constituted a scene of conflict. Hagopian et al reports that in the period 2003-2011, there were between 48,000 and 751,000 excess deaths attributable to the conflict.
In 2014, a new group, Islamic State of Iraq and Syria (ISIS), made significant territorial gains in several governorates in Iraq and captured key cities, including Fallujah and Mosul. ISIS is unique among terrorist groups in that it employs a combination of conventional maneuver warfare tactics with terrorist tactics such as Improvised Explosive Devices (IEDs) and Vehicle-Born Improvised Explosive Devices (VBIEDs) in order to capture and hold territory. These indiscriminate tactics lead to excessive civilian casualties.
In mid-October 2016 the offensive to liberate Mosul started. Emergency Hospital (EH) is one hospital assigned by the Kurdistan Ministry of Health to receive trauma patients from the conflict, and is located in Erbil, around 94 Km east of Mosul. EH is a dedicated trauma hospital that was set up in 1997. Since mid-October 2016 EH is exclusively providing care to injured from the armed conflict. Initially EH and WEH were the only hospitals providing surgical trauma care to patients from Mosul but since late December 2016 secondary facilities have opened closer to Mosul. The two hospitals are since then mainly referral hospitals.
Previous research on trauma from conflict zones generally focus solely on military combatants. Due to the use of ballistic protection and forward surgical teams these results may not be applicable to a civilian setting. A few organizations, such as the Médecins Sans Frontières (MSF), have reported on civilian casualties in conflict zones; however, these have been reports from single centers and articles are sometimes published several years after the trauma occurred. More timely information is needed on the type and pattern of injury for both combatants and civilians. ISIS tactics are likely to have a significant impact on the type of injuries seen at EH. An increased understanding of this impact is essential for addressing emerging resource requirements. The investigators anticipate a high incidence of blast- and firearm-related injuries in both civilians and combatants. This study utilizes existing data from the hospital to gain knowledge of the characteristics of conflict-related injuries, as well as the demographic profile of the patients. Furthermore, the data will be used to investigate how morbidity and mortality varies depending on injury type.
Specific aims:
- Describe the demographics of patients with conflict-related injuries presenting to the EMC during the Mosul campaign.
Describe the morbidity profile of the study population, specifically:
- Determine how markers for injury severity vary with injury mechanism and patient status as combatant or non-combatant.
- Compare how injury mechanism varies with patient identity as non-combatant, ISF or Peshmerga.
- Determine the in-hospital mortality rate.
This is essential both for generating actionable results necessary to direct operational priorities, and gaining an understanding of the wider public health impact of the ongoing conflict. The evidence generated by this study will facilitate effective programmatic monitoring and help optimize resource allocation to meet the rapidly changing health needs in the area.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Stockholm, Sweden
- Karolinska Institute
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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: All patients from Mosul presenting with conflict-related injuries to Emergency Hospital between October 16, 2016 to July 10, 2017.
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Exclusion Criteria:
- Non-conflict related injures, Patients not categorised as either civilian or combatant
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity
Time Frame: October 16, 2016 to July 10, 2017
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Site of injury, mechanism of injury, patient status as combatant or non-combatant
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October 16, 2016 to July 10, 2017
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Mortality
Time Frame: October 16, 2016 to July 10, 2017
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In-hospital mortality
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October 16, 2016 to July 10, 2017
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Collaborators and Investigators
Sponsor
Publications and helpful links
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
- 06032017
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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