Hereditary SpherocytosisVASCUSPHERONCT04451785
Hereditary Spherocytosis and Vascular Function
A study testing blood sample and Pulse wave velocity in people with Hereditary Spherocytosis, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Background : Patients with hereditary spherocytosis (HS) are characterized by increased red blood cell (RBC) fragility and a loss of RBC deformability. While the clinical variability of the disease may be heterogenous from one patient to another, some studies reported the occurrence of vascular complications, notably… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Spherocytosis
- What is being tested?
- blood sample and Pulse wave velocity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Aug 2020to 26 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy controls:
- age ≥ 6 years old
- written, informed and signed consent by the healthy volunteer, or by both parents or legal guardian if the healthy volunteer is a minor
- Healthy volunteer affiliated to a social security scheme or assimilated
- Healthy volunteer not subject to any legal protection measure
- Patients with hereditary spherocytosis:
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- age ≥ 6 years old
- Patient with hereditary or non-splenectomized spherocytosis
- Written, informed and signed consent by the patient, or by at least one of the two parents or legal guardian if the patient is a minor
- Patient affiliated to a social security scheme or assimilated
- Patient not subject to any legal protection measure
Who cannot join
- Healthy controls:
- Pregnant or lactating woman
- Subjects with hereditary spherocytosis or other characterized condition by chronic hemolysis
- Subjects with known pathology affecting the vascular system
- Blood donation (less than a month old)
- Not affiliated to a social security scheme
Show all 12Show fewer
- Patient participating in another interventional research protocol that may interfere with this protocol (according to the investigator's judgment).
- Patients with hereditary spherocytosis:
- Patient who received a blood transfusion in the 3 months preceding
- Pregnant or lactating woman
- Any disease or condition other than hereditary spherocytosis, chronic or not, likely to induce chronic or acute intravascular hemolysis
- Patient participating in another interventional research protocol that may interfere with this protocol (according to the investigator's judgment).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut d'Hématologie et Oncologie PEdiatrique (iHOPe)
Lyon, 69373
Hôpital Edouard Herriot
Lyon, 69437
About this study
Official title: Relationships Between Hemolysis, Erythrosis, Circulating Microparticles and Vascular Function in Patients With Hereditary Spherocytosis
Background : Patients with hereditary spherocytosis (HS) are characterized by increased red blood cell (RBC) fragility and a loss of RBC deformability. While the clinical variability of the disease may be heterogenous from one patient to another, some studies reported the occurrence of vascular complications, notably in patients who have been splenectomized.
Purpose : The aim of the study is to test the associations between the degree of vascular dysfunction and the extent of hemolysis, the amount of circulating microparticles, the level of erythrosis and the degree of RBC biophysical alterations.
Read more
Abstract : Recent studies reported the occurrence of vascular complications in patients with HS, notably in patients who have previously been splenectomized. However, the exact reasons of these complications are unknown and no study investigated the vascular function in HS patients.
Main objective Highlight the presence of altered vascular function in HS patients and test the relationships with the level of hemolysis and circulating microparticles.
Secondary objectives To evaluate the associations between clinical severity and 1) the level of vascular dysfunction and 2) several biomarkers (hemolysis, hematological parameters, circulating microparticles, erythrosis, RBC biophysical properties).
- Conditions
- Hereditary Spherocytosis
- Being tested
- blood sample, Pulse wave velocity
- Keywords
- Hereditary spherocytosis, hemolysis, microparticles, vascular function, red blood cell
- Medical subject headings
- Spherocytosis, Hereditary, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
6 tubes of 4 milliliters (ml) maximum (total: 24 ml) will be sampled for the measurements of the different biological markers. In case of the genetic mutation is already known, only 5 tubes will be collected (total: 20 ml).
Pulse wave velocityDiagnostic test
Non-invasive measurement of pulse wave velocity between the carotid and femoral arteries with piezo-electric sensors.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Active comparator | 20 healthy subjets aged 6 years minimum will be included in this study. This is the control group. Receives: Biological: blood sample; Diagnostic Test: Pulse wave velocity |
| Patients with hereditary spherocytosis | Experimental | 60 patients with hereditary spherocytosis will be included in this study. Receives: Biological: blood sample; Diagnostic Test: Pulse wave velocity |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of pulse wave velocity (PWV)
Vascular function (arterial stiffness) will be investigated by the measurement of pulse wave velocity (PWV). Vascular dysfunction will be defined by a PWV value higher than 6 meter/second (m/s) and 10 m/s in children and adults with HS, respectively.
Measured: Day 1
Secondary outcomes (7)
Hemogram
The hemogram is a complete blood count of the different cell types. All these measures are performed simultaneously on a standard hematology analyzer.
Measured: Day 1
Markers of hemolysis
These markers are measured simultaneously on a standard biochemistry analyzer
Measured: Day 1
Circulating microparticles
Circulating microparticles of various cell origin will be measured by flow cytometry
Measured: Day 1
Markers of erythrosis
Markers of erythrosis (i.e., suicidal death of red blood cells) will be measured by flow cytometry
Measured: Day 1
Blood viscosity
Blood viscosity (expressed in Pa.s) will be measured on a cone-plate viscosimeter, ektacytometry and light transmission, respectively.
Measured: Day 1
Red blood cell deformability
Red blood cell deformability will be measured simultaneously on a Lorrca ektacytometry (Laser-assisted Rotational Red Cell Analyser).
Measured: Day 1
Red blood cell aggregation
Red blood cell aggregation will be measured simultaneously on a Lorrca ektacytometry (Laser-assisted Rotational Red Cell Analyser).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start26 Aug 2020
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hereditary SpherocytosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
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
- NCT04451785
- Sponsor's protocol ID
- 69HCL19_0949
- Other IDs
- 2019-A03203-54
- Acronym
- VASCUSPHERO
- Status last verified
- Apr 2024
- First submitted
- 18 Jun 2020
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Casabianca M, Gauthier A, Nader E, Cannas G, Martin F, Martin M, Carin R, Boisson C, Guillot N, Merazga S, Renoux C, Bertrand Y, Garnier N, Hot A, Muniansi I, Halfon-Domenech C, Poutrel S, Joly P, Connes P. Red blood cell senescence and vascular function in patients with hereditary spherocytosis with and without splenectomy. Br J Haematol. 2024 May;204(5):e41-e44. doi: 10.1111/bjh.19444. Epub 2024 Apr 2. No abstract available.
PubMed 38563320Nemkov T, Connes P, Nader E, Carin R, Casabianca M, Gauthier A, Martin M, Boisson C, Renoux C, Granier N, Hot A, Poutrel S, Cannas G, Bertrand Y, Joly P, D'Alessandro A. Red blood cell metabolome maps disease burden, mutation class, and splenectomy status in hereditary spherocytosis. Blood Red Cells Iron. 2026 Sep 18:100133. doi: 10.1016/j.brci.2026.100133. Online ahead of print.
PubMed 42877681
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Hemolysis, Erythrosis, Circulating Microparticles and Vascular Function in Patients With Hereditary Spherocytosis
- ClinicalTrials.gov ID
- NCT04451785
- Acronym / sponsor ID
- VASCUSPHERO / 69HCL19_0949
- Conditions
- Hereditary Spherocytosis
- Keywords
- Hereditary spherocytosis, hemolysis, microparticles, vascular function, red blood cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 30 Jun 2020 (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.
Background : Patients with hereditary spherocytosis (HS) are characterized by increased red blood cell (RBC) fragility and a loss of RBC deformability. While the clinical variability of the disease may be heterogenous from one patient to another, some studies reported the occurrence of vascular complications, notably in patients who have been splenectomized.
Purpose : The aim of the study is to test the associations between the degree of vascular dysfunction and the extent of hemolysis, the amount of circulating microparticles, the level of erythrosis and the degree of RBC biophysical alterations.
Abstract : Recent studies reported the occurrence of vascular complications in patients with HS, notably in patients who have previously been splenectomized. However, the exact reasons of these complications are unknown and no study investigated the vascular function in HS patients.
Main objective Highlight the presence of altered vascular function in HS patients and test the relationships with the level of hemolysis and circulating microparticles.
Secondary objectives To evaluate the associations between clinical severity and 1) the level of vascular dysfunction and 2) several biomarkers (hemolysis, hematological parameters, circulating microparticles, erythrosis, RBC biophysical properties).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | Active comparator | Biological: blood sample, Diagnostic Test: Pulse wave velocity20 healthy subjets aged 6 years minimum will be included in this study. This is the control group. |
| Patients with hereditary spherocytosis | Experimental | Biological: blood sample, Diagnostic Test: Pulse wave velocity60 patients with hereditary spherocytosis will be included in this study. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- age ≥ 6 years old
- written, informed and signed consent by the healthy volunteer, or by both parents or legal guardian if the healthy volunteer is a minor
- Healthy volunteer affiliated to a social security scheme or assimilated
- Healthy volunteer not subject to any legal protection measure
- age ≥ 6 years old
Key exclusion criteria (12 listed)
- Pregnant or lactating woman
- Subjects with hereditary spherocytosis or other characterized condition by chronic hemolysis
- Subjects with known pathology affecting the vascular system
- Blood donation (less than a month old)
- Not affiliated to a social security scheme
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 |
|---|---|---|
| blood sample6 tubes of 4 milliliters (ml) maximum (total: 24 ml) will be sampled for the measurements of the different biological markers. In case of the genetic mutation is already known, only 5 tubes will be collected (total: 20 ml). | Biological | Healthy individuals, Patients with hereditary spherocytosis |
| Pulse wave velocityNon-invasive measurement of pulse wave velocity between the carotid and femoral arteries with piezo-electric sensors. | Diagnostic test | Healthy individuals, Patients with hereditary spherocytosis |
Primary outcome
measurement of pulse wave velocity (PWV)
Time frame: Day 1
Vascular function (arterial stiffness) will be investigated by the measurement of pulse wave velocity (PWV). Vascular dysfunction will be defined by a PWV value higher than 6 meter/second (m/s) and 10 m/s in children and adults with HS, respectively.
7 secondary outcomes
Hemogram
Time frame: Day 1
Markers of hemolysis
Time frame: Day 1
Circulating microparticles
Time frame: Day 1
Markers of erythrosis
Time frame: Day 1
Blood viscosity
Time frame: Day 1
Red blood cell deformability
Time frame: Day 1
Red blood cell aggregation
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Results publication: PubMed 38563320Casabianca M, Gauthier A, Nader E, Cannas G, Martin F, Martin M, Carin R, Boisson C, Guillot N, Merazga S, Renoux C, Bertrand Y, Garnier N, Hot A, Muniansi I, Halfon-Domenech C, Poutrel S, Joly P, Connes P. Red blood cell senescence and vascular function in patients with hereditary spherocytosis with and without splenectomy. Br J Haematol. 2024 May;204(5):e41-e44. doi: 10.1111/bjh.19444. Epub 2024 Apr 2. No abstract available.
- Derived from this study: PubMed 42877681Nemkov T, Connes P, Nader E, Carin R, Casabianca M, Gauthier A, Martin M, Boisson C, Renoux C, Granier N, Hot A, Poutrel S, Cannas G, Bertrand Y, Joly P, D'Alessandro A. Red blood cell metabolome maps disease burden, mutation class, and splenectomy status in hereditary spherocytosis. Blood Red Cells Iron. 2026 Sep 18:100133. doi: 10.1016/j.brci.2026.100133. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and Pulse wave velocity in people with Hereditary Spherocytosis, run by Hospices Civils de Lyon at 2 sites 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 11 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: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of pulse wave velocity (PWV) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451785, which also lists 2 linked publications.
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 26 Aug 2025.