A Prospective Interventional Physiological Study for Comprehensive Phenotyping of Adults With Non-Life-Threatening Anemia Presenting to the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Correlation coefficient between blood hemoglobin concentration and body weight-normalized total hemoglobin mass
研究概览
简要总结
Anemia is traditionally diagnosed and managed using circulating hemoglobin concentration ([Hb]). However, [Hb] is influenced by plasma volume and may not accurately reflect the total amount of hemoglobin available for oxygen transport. Total hemoglobin mass (Hbmass), measured using the optimized carbon monoxide rebreathing method, provides a direct assessment of the body's oxygen-carrying capacity but has never been extensively investigated in patients presenting to the emergency department with non-life-threatening anemia.
The hypothesis of the PHENOEMEMIA study is that routine blood hemoglobin concentration is only moderately correlated with Hbmass and therefore does not fully reflect the physiological severity of anemia.
PHENOEMEMIA is a prospective single-center interventional physiological study including adults presenting to the emergency department with non-life-threatening anemia. Each participant undergoes routine clinical assessment, standardized symptom questionnaires, additional blood sampling for biological and hemorheological analyses, focused transthoracic echocardiography, near-infrared spectroscopy assessment of tissue oxygenation, and Hbmass measurement using the optimized carbon monoxide rebreathing technique.
The primary objective is to evaluate the correlation between blood hemoglobin concentration and Hbmass normalized to body weight. Secondary objectives include describing the relationships between Hbmass, biological markers of anemia, clinical symptoms, cardiac adaptation, blood rheology, tissue oxygenation, and physiological phenotypes of anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Not applicable. All participants undergo the same study procedures and no masking is performed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older.
- •Presentation to the emergency department.
- •Blood hemoglobin concentration <10 g/dL.
- •Non-life-threatening clinical condition at presentation.
- •Able to understand the study information and provide written informed consent.
- •Affiliated with a health insurance system.
排除标准
- •Glasgow Coma Scale score <
- •Shock Index >0.
- •Acute clinically significant gastrointestinal, gynecological or other active bleeding within the previous 24 hours.
- •Oxygen saturation <92% on room air.
- •Suspected acute myocardial ischemia.
- •Carbon monoxide poisoning.
- •Pregnancy or breastfeeding.
- •Adults lacking legal capacity to provide consent.
- •Individuals deprived of liberty by judicial or administrative decision.
- •Individuals under psychiatric care without consent.
- •Individuals under legal protection (guardianship or curatorship).
- •Individuals not affiliated with a health insurance system.
研究组 & 干预措施
Patient with non-life-threatening anemia
All participants undergo standardized clinical assessment, biological sampling, hemoglobin mass measurement using the optimized carbon monoxide rebreathing technique, focused transthoracic echocardiography, near-infrared spectroscopy, blood rheology assessment and symptom questionnaires during a single study visit
干预措施: Total hemoglobin mass measurement (Device)
Patient with non-life-threatening anemia
All participants undergo standardized clinical assessment, biological sampling, hemoglobin mass measurement using the optimized carbon monoxide rebreathing technique, focused transthoracic echocardiography, near-infrared spectroscopy, blood rheology assessment and symptom questionnaires during a single study visit
干预措施: Focused transthoracic echocardiography (Diagnostic Test)
Patient with non-life-threatening anemia
All participants undergo standardized clinical assessment, biological sampling, hemoglobin mass measurement using the optimized carbon monoxide rebreathing technique, focused transthoracic echocardiography, near-infrared spectroscopy, blood rheology assessment and symptom questionnaires during a single study visit
干预措施: Near-infrared spectroscopy (Diagnostic Test)
Patient with non-life-threatening anemia
All participants undergo standardized clinical assessment, biological sampling, hemoglobin mass measurement using the optimized carbon monoxide rebreathing technique, focused transthoracic echocardiography, near-infrared spectroscopy, blood rheology assessment and symptom questionnaires during a single study visit
干预措施: Blood rheology assessment (Other)
Patient with non-life-threatening anemia
All participants undergo standardized clinical assessment, biological sampling, hemoglobin mass measurement using the optimized carbon monoxide rebreathing technique, focused transthoracic echocardiography, near-infrared spectroscopy, blood rheology assessment and symptom questionnaires during a single study visit
干预措施: Symptom assessment (Other)
结局指标
主要结局
Correlation coefficient between blood hemoglobin concentration and body weight-normalized total hemoglobin mass
时间窗: Baseline (single study visit during emergency department stay)
Correlation between routine blood hemoglobin concentration (g/dL) and total hemoglobin mass normalized to body weight (g/kg) measured using the optimized carbon monoxide rebreathing technique. Pearson's or Spearman's correlation coefficient will be calculated according to data distribution.
次要结局
- Association between total hemoglobin mass and biological markers of anemia(Baseline)
- Association between total hemoglobin mass and clinical manifestations of anemia(Baseline)
- Association between total hemoglobin mass, blood volume and cardiovascular adaptation(Baseline)
- Association between blood rheology and tissue oxygenation(Baseline)