Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05850156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-11
First Post:
2023-04-28
Brief Title:
Study of a Deformability Parameter of Red Blood Cell
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Study of a Deformability Parameter of Red Blood Cell FITRED
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FITRED
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None