Long Term Adverse EffectsNCT03736356
Long-term Health Outcomes of AE Casualties
An observational study of Long Term Adverse Effects and Combat Disorders, run by Ian Stewart at 1 site in United States.
Trial summary
This study involves individuals who are currently participating in the Wounded Warrior Recovery Project and underwent aeromedical evacuation (AE) due to injury during deployment in Iraq or Afghanistan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Adverse Effects, Combat Disorders
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 12 Mar 2020
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be enrolled in the Wounded Warrior Recovery Project and have a record of aeromedical evacuation (AE) due to combat injury in the Expeditionary Medical Encounter database (EMED). Only those who were injured in combat during or after October 2001 and who are currently >18 years old will be enrolled.
Who may be able to join
- Combat injury during or after October 2001
- Aged > 18 years
- Listed in EMED
- Underwent AE
- Enrolled in Wounded Warrior Recovery Project
Who cannot join
- Non-battle injury
- Not listed in EMED
- Combat injury before October 2001
- Did not undergo AE
- Not enrolled in Wounded Warrior Recovery Project
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant USAF Medical Center
Travis Air Force Base, California, 94535
About this study
Official title: Prospective Evaluation of Health Outcomes in AE Casualties: a Pilot Study
This study involves individuals who are currently participating in the Wounded Warrior Recovery Project and underwent aeromedical evacuation (AE) due to injury during deployment in Iraq or Afghanistan. The goal of the study is to understand how best to engage wounded warriors in research activities studying long-term health. Based on the results from this study, the investigators can plan a larger study with the goal to better understand the long-term health conditions of individuals who were injured in combat and improve patient care.
As part of the study, participants will be asked to provide two sets of lab work over the course of a year. Each set of lab work will include one blood draw, one urine sample, and height, weight, and blood pressure measurements. In order to track long-term health, information from participants' lab work will be linked with study-related health data, as well as surveys they have completed with the Wounded Warrior Recovery Project (WWRP).
- Conditions
- Long Term Adverse Effects, Combat Disorders
- Keywords
- Aeromedical Evacuation, Combat Injury
- Medical subject headings
- Long Term Adverse Effects, Combat Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enrolled participants who complete both sets of lab work
Whether or not enrolled participants complete labs as requested at year 1 and year 2
Measured: Approximately one year from beginning of study participation
Secondary outcomes (11)
Complete blood count (CBC)
Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
Comprehensive metabolic panel
Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
Hemoglobin A1c
Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
Cystatin C
Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
High sensitivity C-reactive protein (hs-CRP)
Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
B Type Natriuretic Peptide (BNP)
Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
Urine microalbumin/creatinine ratio
Microalbumin and creatinine will be combined obtain this ratio in mcg/mg creatinine. Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
Blood pressure
Blood pressure measurements will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
Responses from Wounded Warrior Recovery Project surveys
Surveys included in this study will include the most recent Wounded Warrior Recovery Project survey prior to study enrollment, the six month followup survey, and the one year followup survey.
Measured: Approximately one year from beginning of study participation
Height
Height in feet. This measurement will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
Weight
Weight in pounds. This measurement will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Measured: Approximately one year from beginning of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Sep 2018
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: The study was terminated due to the current COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Adverse EffectsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 119 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ian Stewart
- Sponsor type
- US federal agency
- Collaborators
- Naval Health Research Center
- Responsible party
- Sponsor-investigator, Ian Stewart, David Grant U.S. Air Force Medical Center
- Investigators
- Ian J Stewart, MD, Principal investigator, David Grant USAF Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736356
- Sponsor's protocol ID
- FWH20200146H
- Status last verified
- Feb 2022
- First submitted
- 23 Oct 2018
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Health Outcomes in AE Casualties: a Pilot Study
- ClinicalTrials.gov ID
- NCT03736356
- Acronym / sponsor ID
- FWH20200146H
- Conditions
- Long Term Adverse Effects, Combat Disorders
- Keywords
- Aeromedical Evacuation, Combat Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated due to the current COVID-19 pandemic.
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Ian StewartUS federal agency
- Collaborators
- Naval Health Research Center
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 9 Nov 2018 (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.
This study involves individuals who are currently participating in the Wounded Warrior Recovery Project and underwent aeromedical evacuation (AE) due to injury during deployment in Iraq or Afghanistan. The goal of the study is to understand how best to engage wounded warriors in research activities studying long-term health. Based on the results from this study, the investigators can plan a larger study with the goal to better understand the long-term health conditions of individuals who were injured in combat and improve patient care.
As part of the study, participants will be asked to provide two sets of lab work over the course of a year. Each set of lab work will include one blood draw, one urine sample, and height, weight, and blood pressure measurements. In order to track long-term health, information from participants' lab work will be linked with study-related health data, as well as surveys they have completed with the Wounded Warrior Recovery Project (WWRP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be enrolled in the Wounded Warrior Recovery Project and have a record of aeromedical evacuation (AE) due to combat injury in the Expeditionary Medical Encounter database (EMED). Only those who were injured in combat during or after October 2001 and who are currently >18 years old will be enrolled.
Key inclusion criteria (5 listed)
- Combat injury during or after October 2001
- Aged > 18 years
- Listed in EMED
- Underwent AE
- Enrolled in Wounded Warrior Recovery Project
Key exclusion criteria (5 listed)
- Non-battle injury
- Not listed in EMED
- Combat injury before October 2001
- Did not undergo AE
- Not enrolled in Wounded Warrior Recovery Project
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
Number of enrolled participants who complete both sets of lab work
Time frame: Approximately one year from beginning of study participation
Whether or not enrolled participants complete labs as requested at year 1 and year 2
11 secondary outcomes
Complete blood count (CBC)
Time frame: Approximately one year from beginning of study participation
Comprehensive metabolic panel
Time frame: Approximately one year from beginning of study participation
Hemoglobin A1c
Time frame: Approximately one year from beginning of study participation
Cystatin C
Time frame: Approximately one year from beginning of study participation
High sensitivity C-reactive protein (hs-CRP)
Time frame: Approximately one year from beginning of study participation
B Type Natriuretic Peptide (BNP)
Time frame: Approximately one year from beginning of study participation
Urine microalbumin/creatinine ratio
Time frame: Approximately one year from beginning of study participation
Blood pressure
Time frame: Approximately one year from beginning of study participation
Responses from Wounded Warrior Recovery Project surveys
Time frame: Approximately one year from beginning of study participation
Height
Time frame: Approximately one year from beginning of study participation
Weight
Time frame: Approximately one year from beginning of study participation
Results and safety
The study was stopped early (reason given: The study was terminated due to the current COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Ian J Stewart, MD principal investigator
David Grant USAF Medical Center
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 Long Term Adverse Effects and Combat Disorders, run by Ian Stewart at 1 site in United States.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Feb 2022. 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 United States. 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 was stopped early (reason given: The study was terminated due to the current COVID-19 pandemic.). Results are not available in the source record.
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?
Number of enrolled participants who complete both sets of lab work (time frame: Approximately one year from beginning of study participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2022.