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.
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
- Conditions the study is for
- Wounds and Injuries, War-Related Injuries, Gunshot Wound
- 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.
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:
- 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.
- 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.
Morbidity
Site of injury, mechanism of injury, patient status as combatant or non-combatant
Measured: October 16, 2016 to July 10, 2017
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.
- First posted2 Dec 2017
- Study start16 Oct 2016
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian Nerlander, Karolinska Institutet
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Morbidity and Mortality Study of Conflict-Related Injuries: Erbil, Iraq
- ClinicalTrials.gov ID
- NCT03358758
- Acronym / sponsor ID
- 06032017
- Keywords
- Trauma, War-Related Injuries, Firearm, Explosion, Bomb, Ordnance, IED, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,832 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 16 Oct 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Civilians and combatants injured in Mosul
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Non-conflict related injures, Patients not categorised as either civilian or combatant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morbidity
Time frame: October 16, 2016 to July 10, 2017
Site of injury, mechanism of injury, patient status as combatant or non-combatant
Mortality
Time frame: October 16, 2016 to July 10, 2017
In-hospital mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Derived from this study: PubMed 30357467Nerlander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.