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临床试验/NCT04106401
NCT04106401Enrolling By Invitation不适用

Alterations in Total Red Blood Cell Volume and Plasma Volume During a One-year Confinement in Antarctica: Effect of Hypoxia

Ecole Nationale des Sports de Montagne2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
24
试验地点
2
主要终点
total hemoglobin mass

研究概览

简要总结

This study evaluates the effect of hypoxia on blood volumes during Antarctic winter-over confinement. Half of the participants will be evaluated during sea-level winter-over confinement, while the other half will be examined during high-altitude hypoxia winter-over confinement.

详细描述

INTRODUCTION

Short-term space flight induces an alteration of circulating blood volumes, termed "space flight anemia" and characterized by a decrease in total red blood cell volume (RCV) and plasma volume (PV). This haematological alteration is likely to persist during a long-term space mission and impact the astronauts' health, however this question remains unexplored. During a long-term space mission, the use of hypobaric hypoxia is considered for technical reasons, however the safety of hypoxia must first be verified because this environmental condition causes substantial physiological changes, in particular changes in blood volumes that may interact with the haematological effects of microgravity.

OBJECTIVE

using the Antarctic confinement model as a high-fidelity terrestrial analogue for long-duration space missions, the investigators hypothesize that 1) sea level confinement reduces blood volume by simultaneously decreasing RCV and PV, and 2) chronic hypoxia offsets the decrease in RCV and exacerbates the decrease in PV induced by confinement.

METHODS: blood volumes will be measured via the carbon-monoxide rebreathing method, repeatedly in two groups of participants, overwintering either at Dumont d'Urville (sea level) or Concordia (altitude 3200 m). The blood viscosity will also be measured, as well as the markers of erythropoiesis and iron metabolism.

PERSPECTIVE: Documenting if some degree of hypoxia during long-duration confinement may be beneficial or unfavorable in terms of blood volume regulation is potentially relevant information for the astronauts' health and safety during long-duration space missions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Affiliated to a social security scheme
  • Ability to communicate and read in English or in French
  • Signed written informed consent form after visit with a MD

排除标准

  • Pregnant, lactating or parturient women
  • Cardiovascular, pulmonary or neuromuscular disease
  • Vulnerable persons

结局指标

主要结局

total hemoglobin mass

时间窗: 15 months

Physiological parameter, corresponding to the total amount of circulating hemoglobin, expressed in grams, and determined with the 10-min carbon-monoxide rebreathing method and blood carboxyhemoglobin measurements (expressed in %).

total blood volume

时间窗: 15 months

Physiological parameter, corresponding the the total volume of blood, expressed in liters, and derived from total red blood cell volume and hematocrit.

total red blood cell volume

时间窗: 15 months

Physiological parameter, corresponding to the total volume of circulating red blood cells, expressed in liters, and derived from total hemoglobin mass, hematocrit (expressed in fraction) and hemoglobin concentration (expressed in gram per deciliter).

plasma volume

时间窗: 15 months

Physiological parameter, corresponding to the total volume of plasma, expressed in liters, and derived from total blood volume and total red blood cell volume.

次要结局

  • blood viscosity(15 months)
  • serum erythropoietin(15 months)
  • serum hepcidin(15 months)
  • serum erythroferrone(15 months)
  • serum transferrin saturation(15 months)
  • serum ferritin(15 months)
  • serum soluble transferrin receptor(15 months)
  • Physical activity(15 months)
  • Apnea-hypopnea index(15 months)
  • Nocturnal oxygenation(15 months)
  • 24-hour blood pressure(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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