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Recruiting NCT05376046

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

Observational Sickle Cell Disease Vaso-occlusive Crisis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erythrocytic parameters and thrombin generation assay measurement.
Who it may be relevant to
Registry conditions: Sickle Cell Disease, Vaso-occlusive Crisis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease

Overview

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.

Interventions

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

Primary outcome measures

  • Hospitalisation for Vaso-occlusive crisis within one years [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Sickle cell disease

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Rouen university Hospital — Rouen

Publications

  • Feugray G, Grall M, Gillardin B, Burdeau J, Ozanne N, Dumesnil C, Fauvel C, Billoir P. Hemoglobin and High-Density Lipoprotein as Biomarker of Left Atrial Dilatation in Sickle Cell Disease. EJHaem. 2025 Aug 22;6(4):e70135. doi: 10.1002/jha2.70135. eCollection 2025 Aug. PMID 40862241

Identifiers

NCT: NCT05376046 · 2021/0328/OB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗