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NCT Number: NCT07761104

Phenotyping Acute Non-Severe Anemia in the Emergency Department

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency department, Edouard Herriot Hospital, Hospices Civils de Lyon

Lyon, 69003, France

Location contact

Fabien COISY, MD

CONTACT

[email protected]

6 12 19 43 69 ext. +33

Fabien COISY, MD

SUB_INVESTIGATOR

Virginie-Eve LVOVSCHI, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Glasgow Coma Scale score <15.
  • Shock Index >0.9.
  • 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.

Treatment and study plan

Total hemoglobin mass measurement

Device

Measurement of total hemoglobin mass using the optimized carbon monoxide rebreathing technique with capillary carboxyhemoglobin assessment.

Focused transthoracic echocardiography

Diagnostic Test

Standardized focused transthoracic echocardiography including assessment of stroke volume, cardiac output and left ventricular filling parameters

Near-Infrared Spectroscopy

Diagnostic Test

Non-invasive assessment of tissue oxygen saturation and microvascular reactivity using near-infrared spectroscopy.

Blood rheology assessment

Other

Laboratory assessment of blood viscosity, red blood cell deformability and aggregation from additional blood samples.

Symptom assessment

Other

Assessment of fatigue, dyspnea, quality of life and anemia-related symptoms using standardized questionnaires.

Primary outcomes

  1. Correlation coefficient between blood hemoglobin concentration and body weight-normalized total hemoglobin mass

    Time frame: 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.

Secondary outcomes

  1. Association between total hemoglobin mass and biological markers of anemia

    Time frame: Baseline

    Correlation between total hemoglobin mass and routine biological markers including mean corpuscular volume, mean corpuscular hemoglobin concentration, reticulocyte count, ferritin, transferrin saturation, soluble transferrin receptor, C-reactive protein, vitamin B12 and folate concentrations.

  2. Association between total hemoglobin mass and clinical manifestations of anemia

    Time frame: Baseline

    Association between total hemoglobin mass and fatigue (MFI-20), dyspnea (mMRC), quality of life (EQ-5D-5L), and anemia-related symptoms including palpitations, chest pain and headache.

  3. Association between total hemoglobin mass, blood volume and cardiovascular adaptation

    Time frame: Baseline

    Correlation between total hemoglobin mass, blood volume parameters and focused transthoracic echocardiographic measurements including stroke volume, cardiac output, velocity-time integral, mitral inflow velocities and Mitral Annular Plane Systolic Excursion (MAPSE).

  4. Association between blood rheology and tissue oxygenation

    Time frame: Baseline

    Association between blood viscosity, red blood cell deformability, red blood cell aggregation and tissue oxygenation assessed by near-infrared spectroscopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabien COISY, MD

CONTACT

[email protected]

6 12 19 43 69 ext. +33

Virginie-Eve LVOVSCHI, MD

CONTACT

[email protected]

4 72 11 07 67 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

A Prospective Interventional Physiological Study for Comprehensive Phenotyping of Adults With Non-Life-Threatening Anemia Presenting to the Emergency Department

Acronym: PHENOEMEMIA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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