Long-term Health Outcomes of AE Casualties

NCT03736356 | Terminated

• 1 other identifier: FWH20200146H
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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).

Conditions

Long Term Adverse Effects; Combat Disorders

Keywords

Aeromedical Evacuation; Combat Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Complete blood count (CBC)

  Approximately one year from beginning of study participation

• Comprehensive metabolic panel

  Approximately one year from beginning of study participation

• Hemoglobin A1c

  Approximately one year from beginning of study participation

• Cystatin C

  Approximately one year from beginning of study participation

• High sensitivity C-reactive protein (hs-CRP)

  Approximately one year from beginning of study participation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Combat injury during or after October 2001
• Aged \> 18 years
• Listed in EMED
• Underwent AE
• Enrolled in Wounded Warrior Recovery Project

You may not qualify if:

• Non-battle injury
• Not listed in EMED
• Combat injury before October 2001
• Did not undergo AE
• Not enrolled in Wounded Warrior Recovery Project

Sponsors & Collaborators

• Ian Stewart: lead
• Naval Health Research Center: collaborator

Study Sites (1)

David Grant USAF Medical Center

Travis Air Force Base, California, 94535, United States

Location

Biospecimen

Retention: NONE RETAINED

Urine and blood samples

MeSH Terms

Conditions

Long Term Adverse Effects; Combat Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Ian J Stewart, MD

  David Grant USAF Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Combat Nephrology

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 9, 2018
• Study Start: September 1, 2018
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)