Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease (SCD-TGA)

BILLOIR

Status: Enrolling

Conditions: Vaso-occlusive Crisis; Sickle Cell Disease

Treatments: Biological: Erythrocytic parameters and thrombin generation assay measurement

Study type: Observational

Funder types: Other

Identifiers

NCT05376046

2021/0328/OB

Details and patient eligibility

About

Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation.

The aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Sickle cell disease

Exclusion criteria

• <18 years
• pregnancy
• Patient under protective guardianship or curatorship

Trial design

200 participants in 2 patient groups

Sickle cell disease

Description:

Confirmed sickle cell disease withHaemoglobin profile was determined by high performance liquid chromatography (HPLC) (Variant II Biorad, California, United States), by capillary electrophoresis on Capillarys 3 Octa® (Kit hydragel hémoglobine Sebia, Lisses, France) and iso-electrofocalisation. Patients were included during injury evaluation in our tertiary centre.

Treatment:

Biological: Erythrocytic parameters and thrombin generation assay measurement

Healthy

Description:

25 healthy controls matched on age and gender

Treatment:

Biological: Erythrocytic parameters and thrombin generation assay measurement