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NCT05376046 Clinical Trial

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

Sickle Cell Disease Clinical Trial

— SCD-TGA  

Official title:
Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05376046
Other study ID # 2021/0328/OB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date September 1, 2026

Study information
Verified date May 2022
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Sickle cell disease Exclusion Criteria: - <18 years - pregnancy - Patient under protective guardianship or curatorship

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Erythrocytic parameters and thrombin generation assay measurement
Erythrocytic parameters and thrombin generation assay measurement

Locations
Country Name City State
France Rouen university Hospital Rouen

Sponsors (1)
Lead Sponsor Collaborator
BILLOIR

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalisation for Vaso-occlusive crisis within one years Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year 1 year
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