Long-term Health Outcomes of AE Casualties

Terminated

• Conditions: Combat Disorders; Long Term Adverse Effects

• Registration Number: NCT03736356
• Lead Sponsor: Ian Stewart

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of enrolled participants who complete both sets of lab work	Approximately one year from beginning of study participation	Whether or not enrolled participants complete labs as requested at year 1 and year 2

Secondary Outcome Measures

Name	Time	Method
Complete blood count (CBC)	Approximately one year from beginning of study participation	Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Comprehensive metabolic panel	Approximately one year from beginning of study participation	Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Hemoglobin A1c	Approximately one year from beginning of study participation	Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Cystatin C	Approximately one year from beginning of study participation	Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
High sensitivity C-reactive protein (hs-CRP)	Approximately one year from beginning of study participation	Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
B Type Natriuretic Peptide (BNP)	Approximately one year from beginning of study participation	Results from this lab test will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Blood pressure	Approximately one year from beginning of study participation	Blood pressure measurements will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Height	Approximately one year from beginning of study participation	Height in feet. This measurement will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.
Urine microalbumin/creatinine ratio	Approximately one year from beginning of study participation	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.
Responses from Wounded Warrior Recovery Project surveys	Approximately one year from beginning of study participation	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.
Weight	Approximately one year from beginning of study participation	Weight in pounds. This measurement will be used to define physical health outcomes of patients who have transited through the aeromedical evacuation system.

Trial Locations

Locations (1)

David Grant USAF Medical Center; 🇺🇸 Travis Air Force Base, California, United States