Hereditary Spherocytosis and Vascular Function (VASCUSPHERO)

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    80
  • sponsor
    Hospices Civils de Lyon
Updated on 24 April 2022
Accepts healthy volunteers

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 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).

Details
Condition Hereditary Spherocytosis
Treatment Blood sample, Pulse Wave Velocity
Clinical Study IdentifierNCT04451785
SponsorHospices Civils de Lyon
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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)
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