Study of a Deformability Parameter of Red Blood Cell
FITRED
1 other identifier
observational
130
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Sep 2023
Typical duration for all trials
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 11, 2023
April 1, 2023
3 years
April 28, 2023
May 10, 2023
Conditions
Outcome Measures
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.
14 months
Secondary Outcomes (3)
Effect of ambient temperature during fTT measurement
14 months
Effect of the processing time on fTT measurement
14 months
Correlation of ftt with the collected data
14 months
Study Arms (4)
Adult sickle cell patients
In the context of routine care, 3 blood collection will be performed on adult sickle cell patients for the analysis of hemoglobin fractions. For each blood collection, an additional volume of blood will be taken for the research purposes.
pediatric sickle cell patients
In the context of routine care, 3 blood collection will be performed on pediatric sickle cell patients for the analysis of hemoglobin fractions. For each blood collection, an additional volume of blood will be taken for the research purposes.
Adult sickle cell carriers (heterozygous patients)
In the context of neonatal screening for sickle cell disease, the parents will be called altogether with their children in order to check if they are sickle cell carriers or not. Only 1 blood collection will be performed for this group.
Control patients
In the context of neonatal screening for sickle cell disease, the parents will be called altogether with their children in order to check if they are sickle cell carriers or not. Only 1 blood collection will be performed for this group.
Interventions
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
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
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
Eligibility Criteria
Adult and pediatric sickle cell patients, adult sickle cell carriers (heterozygous), and adult control subjects (homozygous).
You may qualify if:
- Repeatability of ftt (mechanical marker of deformability) measurements
You may not qualify if:
- Effect of ambient temperature on ftt measurements
- Effect of sample processing time on ftt measurements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 9, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
May 11, 2023
Record last verified: 2023-04