Long-term Health Outcomes of AE Casualties

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).

Study Overview

• Status: Terminated
• Conditions: Combat Disorders; Long Term Adverse Effects

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• United States
  • California
    • Travis Air Force Base, California, United States, 94535
      • David Grant USAF Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Approximately one year from beginning of study participation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Approximately one year from beginning of study participation

Collaborators and Investigators

• Sponsor: Ian Stewart
• Collaborators: Naval Health Research Center
• Investigators: Principal Investigator: Ian J Stewart, MD, David Grant USAF Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Aeromedical Evacuation; Combat Injury
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Combat Disorders; Long Term Adverse Effects
• Other Study ID Numbers: FWH20200146H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No