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

Recruiting

• Conditions: Vaso-occlusive Crisis; Sickle Cell Disease
• Interventions: Biological: Erythrocytic parameters and thrombin generation assay measurement

• Registration Number: NCT05376046
• Lead Sponsor: BILLOIR

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2022-04-29
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-17
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Sickle cell disease

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sickle cell disease	Erythrocytic parameters and thrombin generation assay measurement	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.
Healthy	Erythrocytic parameters and thrombin generation assay measurement	25 healthy controls matched on age and gender

Primary Outcome Measures

Name	Time	Method
Hospitalisation for Vaso-occlusive crisis within one years	1 year	Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year

Trial Locations

Locations (1)

Rouen university Hospital; 🇫🇷 Rouen, France