Long-term Health Outcomes of AE Casualties

Sponsor
Ian Stewart (U.S. Fed)
Overall Status
Terminated
CT.gov ID
NCT03736356
Collaborator
Naval Health Research Center (U.S. Fed)
119
1
18.3
6.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    119 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Evaluation of Health Outcomes in AE Casualties: a Pilot Study
    Actual Study Start Date :
    Sep 1, 2018
    Actual Primary Completion Date :
    Mar 12, 2020
    Actual Study Completion Date :
    Mar 12, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    11. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 David Grant USAF Medical Center Travis Air Force Base California United States 94535

    Sponsors and Collaborators

    • Ian Stewart
    • Naval Health Research Center

    Investigators

    • Principal Investigator: Ian J Stewart, MD, David Grant USAF Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ian Stewart, Chief, Combat Nephrology, David Grant U.S. Air Force Medical Center
    ClinicalTrials.gov Identifier:
    NCT03736356
    Other Study ID Numbers:
    • FWH20200146H
    First Posted:
    Nov 9, 2018
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ian Stewart, Chief, Combat Nephrology, David Grant U.S. Air Force Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 16, 2022