Long-term Health Outcomes of AE Casualties

Combat Disorders Clinical Trial

Official title:

Prospective Evaluation of Health Outcomes in AE Casualties: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03736356
• Other study ID #: FWH20200146H
• Status: Terminated
• Start date: September 1, 2018
• Est. completion date: March 12, 2020

Study information

• Verified date: February 2022
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 119
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Combat Disorders
• Long Term Adverse Effects

Locations

Country	Name	City	State
United States	David Grant USAF Medical Center	Travis Air Force Base	California

Sponsors (2)

Lead Sponsor	Collaborator
Ian Stewart	Naval Health Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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