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Wounds and InjuriesNCT03358758

Retrospective Morbidity and Mortality Study of Conflict-Related Injuries: Erbil, Iraq

An observational study of Wounds and Injuries and War-Related Injuries, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A retrospective morbidity and mortality study, using routinely collected data, investigating the epidemiology of patients with conflict-related injuries presenting to a dedicated trauma hospital in Erbil, Iraq, during the campaign to liberate Mosul from ISIS. Read more about this study

Who is it for?
Ages Up to 99 years
How many people
1,832 participants
Where
1 siteSweden
Study dates
16 Oct 2016to 10 Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 99 years
  • All sexes
  • Child, Adult, Older adult

Study population: Civilians and combatants injured in Mosul

Who may be able to join

None listed.

Who cannot join

  • Non-conflict related injures, Patients not categorised as either civilian or combatant

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska Institute

    Stockholm

Other trials in Sweden

About this study

A retrospective morbidity and mortality study, using routinely collected data, investigating the epidemiology of patients with conflict-related injuries presenting to a dedicated trauma hospital in Erbil, Iraq, during the campaign to liberate Mosul from ISIS.

Read the 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:

  1. Describe the demographics of patients with conflict-related injuries presenting to the EMC during the Mosul campaign.
  2. Describe the morbidity profile of the study population, specifically:
  3. Determine how markers for injury severity vary with injury mechanism and patient status as combatant or non-combatant.
  4. Compare how injury mechanism varies with patient identity as non-combatant, ISF or Peshmerga.
  5. 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.

Keywords
Trauma, War-Related Injuries, Firearm, Explosion, Bomb, Ordnance, IED, Epidemiology, Public Health
Medical subject headings
Wounds and Injuries, War-Related Injuries, Wounds, Gunshot, Blast Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity

    Site of injury, mechanism of injury, patient status as combatant or non-combatant

    Measured: October 16, 2016 to July 10, 2017

  2. Mortality

    In-hospital mortality

    Measured: October 16, 2016 to July 10, 2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2017
  2. Study start16 Oct 2016
  3. Primary completion10 Jul 2017
  4. Study completion10 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,832 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03358758
Sponsor's protocol ID
06032017
Status last verified
Nov 2017
First submitted
27 Nov 2017
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nerlander MP, Haweizy RM, Wahab MA, Alga A, von Schreeb J. Epidemiology of Trauma Patients from the Mosul Offensive, 2016-2017: Results from a Dedicated Trauma Center in Erbil, Iraqi Kurdistan. World J Surg. 2019 Feb;43(2):368-373. doi: 10.1007/s00268-018-4817-1.

    PubMed 30357467

Questions about this trial

What is this clinical trial studying?

An observational study of Wounds and Injuries and War-Related Injuries, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morbidity (time frame: October 16, 2016 to July 10, 2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03358758, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.

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