Phenotyping Acute Non-Severe Anemia in the Emergency Department

NCT07761104 | Not Yet Recruiting

• 1 other identifier: 69HCL26_0668
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Anemia

Keywords

Anemia; Hemoglobin Mass; Carbon Monoxide Rebreathing; Emergency Medicine; Blood Volume; Hemorheology; Tissue Oxygenation; Near Infrared Spectroscopy; Echocardiography; Physiological Phenotyping

Outcome Measures

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.

  Baseline (single study visit during emergency department stay)

Secondary Outcomes (4)

• 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

Study Arms (1)

Patient with non-life-threatening anemia

OTHER

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

Device: Total hemoglobin mass measurement; Diagnostic Test: Focused transthoracic echocardiography; Diagnostic Test: Near-infrared spectroscopy; Other: Blood rheology assessment; Other: Symptom assessment

Interventions

Total hemoglobin mass measurement DEVICE

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

Patient with non-life-threatening anemia

Focused transthoracic echocardiography DIAGNOSTIC_TEST

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

Patient with non-life-threatening anemia

Near-infrared spectroscopy DIAGNOSTIC_TEST

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

Patient with non-life-threatening anemia

Blood rheology assessment OTHER

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

Patient with non-life-threatening anemia

Symptom assessment OTHER

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

Patient with non-life-threatening anemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Emergency department, Edouard Herriot Hospital, Hospices Civils de Lyon

Lyon, 69003, France

Location

MeSH Terms

Conditions

Anemia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Fabien COISY, MD

CONTACT

6 12 19 43 69; fabien.coisy@chu-lyon.fr

Virginie-Eve LVOVSCHI, MD

CONTACT

4 72 11 07 67; virginie.lvovschi@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not applicable. All participants undergo the same study procedures and no masking is performed.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, single-arm physiological study in which 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.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

FR (1)