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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thrombophilia Vaso-Occlusive Crises Vaso-occlusive Crisis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rouen university Hospital

Rouen, 76000, France

Location status: Recruiting

Location contact

Paul Billoir, PhD, associate professor

CONTACT

[email protected]

+33232888129

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Sickle cell disease

Exclusion criteria

<18 years
pregnancy
Patient under protective guardianship or curatorship

Treatment and study plan

Erythrocytic parameters and thrombin generation assay measurement

Biological

Erythrocytic parameters and thrombin generation assay measurement

Primary outcomes

Hospitalisation for Vaso-occlusive crisis within one years

Time frame: 1 year

Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year

Sponsors and collaborators

Lead sponsor

BILLOIR

Other

Registry information

Official study title

Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease

Acronym: SCD-TGA

Important dates

Study start: 2018
Primary completion: 2025
Study completion: 2026
First posted: May 17, 2022
Registry last updated: May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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