Study of a Deformability Parameter of Red Blood Cell. FITRED
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Drepanocytosis
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Enrollment
- 130
- Primary Endpoint
- repeatability of fTT measurements
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Repeatability of ftt (mechanical marker of deformability) measurements
Exclusion Criteria
- •Effect of ambient temperature on ftt measurements
- •Effect of sample processing time on ftt measurements
Outcomes
Primary Outcomes
repeatability of fTT measurements
Time Frame: 14 months
A series of 10 measurements of a deformability of red blood cells parameter (fTT) on the same blood sample will be performed successively within 24 hours for 4 samples (2 from sickle cell patient and 2 from control or heterozygous patients). The repeatability of the measurements will be determined from these measurements and the effect of a variation in the total number of red blood cells will be analyzed.This study will be reproduced on several blood samples and the measurements will be repeated under the same conditions 24 hours later.
Secondary Outcomes
- Correlation of ftt with the collected data(14 months)
- Effect of ambient temperature during fTT measurement(14 months)
- Effect of the processing time on fTT measurement(14 months)