MedTrace Logo

Study of a Deformability Parameter of Red Blood Cell

NCT05850156 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2023-05-11

No results posted yet for this study

Summary

Sickle-cell disease is one of the most common severe monogenic disorders in the world, it results in the synthesis of abnormal hemoglobin (HbS) instead of hemoglobin A. When deoxygenated, the sickle haemoglobin (HbS) polymerizes inducing the sickling of red blood cells (RBCs) and leading to decreased deformability and increased fragility. Therefore, sickle RBCs exhibit a reduced lifespan associated with intravascular hemolysis, hemolytic anemia and low tissue oxygenation. Sickle RBCs, which exhibit abnormal adhesive properties to endothelial cells, can block the microcirculation, causing the occurrence of painful vaso-occlusive crisis (VOC), acute chest syndrome (ACS), acute and chronic organ damage (heart, lung, liver, spleen, kidney, bone…) and shortened life span.

A preliminary study performed on RBC from sickle cell patients (Hb SS) has shown an alteration of a parameter measuring the overall deformability of RBCs by evaluating the nature of their movement in a shear flow. This parameter is significantly lower in sickle cell patients in steady state compared to a population of healthy individuals. The parameter is also significantly lower in sickle cell patients during VOC when compared to patient in steady state.

The main objective of this study is to evaluate the performance of the method for measuring the deformability of RBCs on an experimental prototype. Measurements will be performed on blood samples from subjects with a normal hemoglobin electrophoretic profile, from heterozygous carriers of sickle cell disease and from patients with sickle cell disease. Samples from paediatric patients will also be tested to study any specificity in comparison to adult subjects.

Conditions

  • Drepanocytosis

Interventions

PROCEDURE

basal blood collection

blood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study

PROCEDURE

blood collection M6

6 months +/- 2 months after inclusion, a blood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study

PROCEDURE

blood collection M12

12 months +/- 2 months after inclusion, a blood collection is performed in the context of routine care for hemoglobin analysis. An additional volume of 300µL of blood is taken for the purposes of the study

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2026-09-30
Completion
2027-03-31

More Related Trials

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 NCT05850156 on ClinicalTrials.gov