AnemiaPHENOEMEMIANCT07761104
Phenotyping Acute Non-Severe Anemia in the Emergency Department
A study testing Total hemoglobin mass measurement, Focused transthoracic echocardiography and Near-infrared spectroscopy in people with Anemia, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Total hemoglobin mass measurement, Focused transthoracic echocardiography and Near-infrared spectroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Emergency department, Edouard Herriot Hospital, Hospices Civils de Lyon
Lyon, 69003
Fabien COISY, MD, 6 12 19 43 69 ext. +33, fabien.coisy@chu-lyon.fr
Virginie-Eve LVOVSCHI, MD
About this study
Official title: A Prospective Interventional Physiological Study for Comprehensive Phenotyping of Adults With Non-Life-Threatening Anemia Presenting to 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.
Read more
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
- Being tested
- Total hemoglobin mass measurement, Focused transthoracic echocardiography, Near-infrared spectroscopy, Blood rheology assessment, Symptom assessment
- Keywords
- Anemia, Hemoglobin Mass, Carbon Monoxide Rebreathing, Emergency Medicine, Blood Volume, Hemorheology, Tissue Oxygenation, Near Infrared Spectroscopy, Echocardiography, Physiological Phenotyping
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hemoglobin mass measurementDevice
Measurement of total hemoglobin mass using the optimized carbon monoxide rebreathing technique with capillary carboxyhemoglobin assessment.
Focused transthoracic echocardiographyDiagnostic test
Standardized focused transthoracic echocardiography including assessment of stroke volume, cardiac output and left ventricular filling parameters
Near-infrared spectroscopyDiagnostic test
Non-invasive assessment of tissue oxygen saturation and microvascular reactivity using near-infrared spectroscopy.
Blood rheology assessmentOther
Laboratory assessment of blood viscosity, red blood cell deformability and aggregation from additional blood samples.
Symptom assessmentOther
Assessment of fatigue, dyspnea, quality of life and anemia-related symptoms using standardized questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Total hemoglobin mass measurement; Diagnostic Test: Focused transthoracic echocardiography; Diagnostic Test: Near-infrared spectroscopy; Other: Blood rheology assessment; Other: Symptom assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single study visit during emergency department stay)
Secondary outcomes (4)
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.
Measured: Baseline
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.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761104
- Sponsor's protocol ID
- 69HCL26_0668
- Acronym
- PHENOEMEMIA
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Physiological Study for Comprehensive Phenotyping of Adults With Non-Life-Threatening Anemia Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT07761104
- Acronym / sponsor ID
- PHENOEMEMIA / 69HCL26_0668
- Conditions
- Anemia
- Keywords
- Anemia, Hemoglobin Mass, Carbon Monoxide Rebreathing, Emergency Medicine, Blood Volume, Hemorheology, Tissue Oxygenation, Near Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient with non-life-threatening anemia | Other | Device: Total hemoglobin mass measurement, Diagnostic Test: Focused transthoracic echocardiography, Diagnostic Test: Near-infrared spectroscopy, Other: Blood rheology assessment, Other: Symptom assessmentAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hemoglobin mass measurementMeasurement of total hemoglobin mass using the optimized carbon monoxide rebreathing technique with capillary carboxyhemoglobin assessment. | Device | Patient with non-life-threatening anemia |
| Focused transthoracic echocardiographyStandardized focused transthoracic echocardiography including assessment of stroke volume, cardiac output and left ventricular filling parameters | Diagnostic test | Patient with non-life-threatening anemia |
| Near-infrared spectroscopyNon-invasive assessment of tissue oxygen saturation and microvascular reactivity using near-infrared spectroscopy. | Diagnostic test | Patient with non-life-threatening anemia |
| Blood rheology assessmentLaboratory assessment of blood viscosity, red blood cell deformability and aggregation from additional blood samples. | Other | Patient with non-life-threatening anemia |
| Symptom assessmentAssessment of fatigue, dyspnea, quality of life and anemia-related symptoms using standardized questionnaires. | Other | Patient with non-life-threatening anemia |
Primary outcome
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.
4 secondary outcomes
Association between total hemoglobin mass and biological markers of anemia
Time frame: Baseline
Association between total hemoglobin mass and clinical manifestations of anemia
Time frame: Baseline
Association between total hemoglobin mass, blood volume and cardiovascular adaptation
Time frame: Baseline
Association between blood rheology and tissue oxygenation
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hemoglobin mass measurement, Focused transthoracic echocardiography and Near-infrared spectroscopy in people with Anemia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabien COISY, MD (6 12 19 43 69 ext. +33, fabien.coisy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between blood hemoglobin concentration and body weight-normalized total hemoglobin mass (time frame: Baseline (single study visit during emergency department stay)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.