Phenotyping Acute Non-Severe Anemia in the Emergency Department

NCT07761104 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-08-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Total hemoglobin mass measurement

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

DIAGNOSTIC_TEST

Focused transthoracic echocardiography

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

DIAGNOSTIC_TEST

Near-infrared spectroscopy

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

OTHER

Blood rheology assessment

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

OTHER

Symptom assessment

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761104 on ClinicalTrials.gov