ANEMIA: Causes and Mechanisms of Space Hemolysis at High Altitudes

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05496309
Collaborator
(none)
4
1
15.9
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Study Details

Study Description

Brief Summary

Anemia is a lack of red blood cells (RBCs) in the circulation. Because RBCs carry the oxygen your body needs to function, anemia can affect one's ability to stay awake, alert, and perform physical activities. Anemia may happen for several reasons, including increased RBC destruction. Anemia often occurs in people who have been in bed for long periods (e.g., if they are very sick) or have decreased mobility (anemia of immobility). Interestingly, astronauts who have left Earth and traveled in space also return anemic. In fact, 5 decades of NASA data showed that astronauts' anemia was more severe the longer they were in space. In another study, astronauts aboard the International Space Station were shown to destroy 54% more of their RBCs in space. RBC destruction may be the culprit of space anemia as well as anemia of immobility on Earth. The ANEMIA Study proposes to measure key aspects of RBC destruction in astronauts in space. These measures will test critical hypotheses on the effects of spaceflight on red blood cells.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Causes and Mechanisms of Space Hemolysis at High Altitudes (ANEMIA)
    Actual Study Start Date :
    Aug 2, 2022
    Anticipated Primary Completion Date :
    Nov 30, 2022
    Anticipated Study Completion Date :
    Nov 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Group

    The group is a cohort of 4 persons.

    Outcome Measures

    Primary Outcome Measures

    1. Hemolysis in astronauts is assessed using exhaled breath samples. [Before spaceflight.]

    2. Change from baseline hemolysis in astronauts is assessed during spaceflight using exhaled breath samples. [Baseline and during spaceflight.]

    3. Change from baseline hemolysis in astronauts is assessed after spaceflight, up to 1 month, using exhaled breath samples. [After spaceflight, up to 1 month.]

    4. Hemolysis in astronauts is assessed using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC. [Before spaceflight.]

    5. Change from baseline hemolysis in astronauts is assessed during spaceflight using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC. [Baseline and during spaceflight.]

    6. Change from baseline hemolysis in astronauts is assessed after spaceflight, up to 1 month, using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC. [After spaceflight, up to 1 month.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years to 55 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Astronauts selected to fly on a space mission.
    Exclusion Criteria:
    • Astronauts not selected to fly on a space mission.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ottawa Hospital Research Institute Ottawa Ontario Canada K1Y 4E9

    Sponsors and Collaborators

    • Ottawa Hospital Research Institute

    Investigators

    • Principal Investigator: Guy Trudel, Ottawa Hospital Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Guy Trudel, Professor of Medicine, Surgery and Biochemistry, Ottawa Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT05496309
    Other Study ID Numbers:
    • 0220470-01H
    First Posted:
    Aug 11, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022