Causes and Mechanisms of Space Hemolysis at High Altitudes

Anemia Clinical Trial

— ANEMIA  

Official title:

Causes and Mechanisms of Space Hemolysis at High Altitudes (ANEMIA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496309
• Other study ID #: 0220470-01H
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: Guy Trudel
• Phone: (613) 737-8899
• Email: gtrudel[@]toh.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: November 30, 2024
• Est. primary completion date: July 30, 2024
• Gender: All
• Age group: 24 Years to 55 Years

Eligibility

Inclusion Criteria:

• Astronauts selected to fly on a space mission.

Exclusion Criteria:

• Astronauts not selected to fly on a space mission.

Related Conditions & MeSH terms

• Anemia
• Hemolysis
• Weightlessness

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemolysis in astronauts is assessed using exhaled breath samples.		Before spaceflight.
Primary	Change from baseline hemolysis in astronauts is assessed during spaceflight using exhaled breath samples.		Baseline and during spaceflight.
Primary	Change from baseline hemolysis in astronauts is assessed after spaceflight, up to 1 month, using exhaled breath samples.		After spaceflight, up to 1 month.
Primary	Hemolysis in astronauts is assessed using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC.		Before spaceflight.
Primary	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.
Primary	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.