Clinical trial NCT05496309: Causes and Mechanisms of Space Hemolysis At High Altitudes
Official title: Causes and Mechanisms of Space Hemolysis At High Altitudes (ANEMIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Weightlessness
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 8
Sex: ALL
Minimum age (years): 24
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Astronauts selected to fly on a space mission.

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.


Eligibility criteria: Inclusion Criteria:

* Astronauts selected to fly on a space mission.

Exclusion Criteria:

* Astronauts not selected to fly on a space mission.

Primary outcomes:
measure: Hemolysis in astronauts is assessed using exhaled breath samples.
timeFrame: Before spaceflight.
measure: Change from baseline hemolysis in astronauts is assessed during spaceflight using exhaled breath samples.
timeFrame: Baseline and during spaceflight.
measure: Change from baseline hemolysis in astronauts is assessed after spaceflight, up to 1 month, using exhaled breath samples.
timeFrame: After spaceflight, up to 1 month.
measure: Hemolysis in astronauts is assessed using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC.
timeFrame: Before spaceflight.
measure: Change from baseline hemolysis in astronauts is assessed during spaceflight using blood markers CBC, reticulocytes, haptoglobin, bilirubin (total+direct), LDH, ferritin, iron, and TIBC.
timeFrame: Baseline and during spaceflight.
measure: 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.
timeFrame: After spaceflight, up to 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Guy Trudel
role: PRINCIPAL_INVESTIGATOR
References: