Causes and Mechanisms of Space Hemolysis At High Altitudes

NCT05496309 | Completed

• 1 other identifier: 0220470-01H
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Weightlessness

Outcome Measures

Primary Outcomes (6)

• Hemolysis in astronauts is assessed using exhaled breath samples.

  Before spaceflight.

• Change from baseline hemolysis in astronauts is assessed during spaceflight using exhaled breath samples.

  Baseline and during spaceflight.

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

  After spaceflight, up to 1 month.

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

  Before spaceflight.

• 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.

• 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.

Study Arms (1)

Group

The group is a cohort of 4 persons.

Eligibility Criteria

• Age: 24 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Astronauts selected to fly on a space mission.

You may qualify if:

• Astronauts selected to fly on a space mission.

You may not qualify if:

• Astronauts not selected to fly on a space mission.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Guy Trudel

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Surgery and Biochemistry

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 11, 2022
• Study Start: May 2, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)