Clinical trial NCT03736356: Long-term Health Outcomes of AE Casualties
Official title: Prospective Evaluation of Health Outcomes in AE Casualties: a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Long Term Adverse Effects
Combat Disorders
Keywords: Aeromedical Evacuation
Combat Injury
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
Collaborators: name: Naval Health Research Center
First posted: 2018-11-09
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

1. Combat injury during or after October 2001
2. Aged \> 18 years
3. Listed in EMED
4. Underwent AE
5. Enrolled in Wounded Warrior Recovery Project

Exclusion Criteria:

1. Non-battle injury
2. Not listed in EMED
3. Combat injury before October 2001
4. Did not undergo AE
5. Not enrolled in Wounded Warrior Recovery Project

Primary outcomes:
measure: Number of enrolled participants who complete both sets of lab work
timeFrame: Approximately one year from beginning of study participation
Secondary outcomes:
measure: Complete blood count (CBC)
timeFrame: Approximately one year from beginning of study participation
measure: Comprehensive metabolic panel
timeFrame: Approximately one year from beginning of study participation
measure: Hemoglobin A1c
timeFrame: Approximately one year from beginning of study participation
measure: Cystatin C
timeFrame: Approximately one year from beginning of study participation
measure: High sensitivity C-reactive protein (hs-CRP)
timeFrame: Approximately one year from beginning of study participation
measure: B Type Natriuretic Peptide (BNP)
timeFrame: Approximately one year from beginning of study participation
measure: Urine microalbumin/creatinine ratio
timeFrame: Approximately one year from beginning of study participation
measure: Blood pressure
timeFrame: Approximately one year from beginning of study participation
measure: Responses from Wounded Warrior Recovery Project surveys
timeFrame: Approximately one year from beginning of study participation
measure: Height
timeFrame: Approximately one year from beginning of study participation
measure: Weight
timeFrame: Approximately one year from beginning of study participation
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant USAF Medical Center
state: California
Study officials:
affiliation: David Grant USAF Medical Center
name: Ian J Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References: