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Phenotyping Acute Non-Severe Anemia in the Emergency Department

ConditionAnemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

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

  • Symptom assessment

    Other intervention

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

Treatment groups

59 Participants
are divided into 1 treatment group
Group A: Patient with non-life-threatening anemiaOther 5 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Baseline (single study visit during emergency department stay)

Secondary outcomes

1

Association between total hemoglobin mass and biological markers of anemia

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.

Time frame
Baseline
2

Association between total hemoglobin mass and clinical manifestations of anemia

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.

Time frame
Baseline
3

Association between total hemoglobin mass, blood volume and cardiovascular adaptation

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).

Time frame
Baseline
4

Association between blood rheology and tissue oxygenation

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov

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