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

ConditionsSickle Cell Disease Vaso-occlusive Crisis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBILLOIR

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Sickle cell disease

Disqualifiers

<18 years

pregnancy

Patient under protective guardianship or curatorship

Trial population

All patients in the study were diagnosed and treated for SCD at Rouen University Hospital. Patients were included during annual visit in our tertiary centre. Patients with VOC were included less than 24hours after admission to emergency department. All patients treated with hydroxyurea have been treated for at least three years. All patients received a systematic annual visit to determine VOC development in the year. Patients were analyzed in four subgroups based on genotype and clinical status: * homozygous SCD (S/S) or β0 thalassemia (S/β0) at steady state; * homozygous SCD with α3.7 thalassemia (S/Sα3.7) at steady state; * heterozygous SCD with C haemoglobin (S/C) or β+ thalassemia (S/β+)at steady state; * patients hospitalized for VOC with any genotype.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Erythrocytic parameters and thrombin generation assay measurement
Biological/Vaccine
Erythrocytic parameters and thrombin generation assay measurement

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Sickle cell disease1 intervention

Group B: Healthy1 intervention

Trial outcomes

Primary outcomes

Hospitalisation for Vaso-occlusive crisis within one years

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

Time frame

1 year

Sponsors and contacts

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BILLOIR

Lead sponsor

University Hospital, Rouen

Sponsor institution

Source ClinicalTrials.gov

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