Study of a Deformability Parameter of Red Blood Cell

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Repeatability of ftt (mechanical marker of deformability) measurements

Disqualifiers

Effect of ambient temperature on ftt measurements

Effect of sample processing time on ftt measurements

Trial population

Adult and pediatric sickle cell patients, adult sickle cell carriers (heterozygous), and adult control subjects (homozygous).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • basal blood collection

    Procedure/Surgery

    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

  • blood collection M6

    Procedure/Surgery

    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

  • blood collection M12

    Procedure/Surgery

    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

Treatment groups

130 Participants
are divided into 4 treatment groups
Group A: Adult sickle cell patients3 interventions
Group B: pediatric sickle cell patients3 interventions
Group C: Adult sickle cell carriers (heterozygous patients)1 intervention
Group D: Control patients1 intervention

Trial outcomes

Primary outcomes

1

repeatability of fTT measurements

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.

Time frame
14 months

Secondary outcomes

1

Effect of ambient temperature during fTT measurement

Tests will be conducted to evaluate the effect of ambient temperature on the measurement of a series of 4 samples at ambient temperature (from 18 to 30°C).

Time frame
14 months
2

Effect of the processing time on fTT measurement

test will be conducted to measure the fTT on a series of 10 samples, twice a day during the 2 first days an then every day for 5 days.

Time frame
14 months
3

Correlation of ftt with the collected data

A correlation study of ftt with socio-demographic (age and sex), biological (results of hemogram and hemoglobin electrophoresis) and clinical (number of vaso-occlusive crises and treatment with Hydroxyurea) will be conducted.

Time frame
14 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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