Comparison of Thrombin Generation, Platelet Activation and Aggregation Profiles in Patients With Sickle Cell Disease Depending on Their SS or SC Genotype (DrepAgreg)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de la Guadeloupe

About this trial

Sickle cell disease (SCD) is characterized by chronic hemolytic anemia, painful crises called vaso-occlusive crises (VOC) and chronic inflammation. Activated platelets from SCD patients contribute to both chronic inflammation and painful VOC. Individuals with the HbSC genotype experience anemia and less severe clinical manifestations than those with the HbSS genotype; however, they are at higher risk of venous thromboembolic events, particularly pulmonary embolism.

This study aims to investigate whether sickle cell patients exhibit different thrombin generation profiles as well as distinct platelet activation and aggregation profiles, depending on their SS or SC genotype.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

SCD patients with SS or SC

diagnosis of SCD performed by electrophoresis or high-performance liquid chromatography (HPLC) in a reference laboratory for hemoglobinopathies

patients older than 18 years at inclusion

clinically in a steady state at inclusion (no complication in the last month and no transfusion in the three last months)

Disqualifiers

patients younger than 18 years old

patients with hemoglobinopathy other than SS and SC SCD

patients who have received transfusion therapy or on bleeding therapy for less than three months

patients no affiliated with national social security

Trial population

Patients with sickle cell disease and the HbSS or HbSC genotype recruited from the participating study centers in Guadeloupe or Bobigny

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: SS Group
Group B: SC Group

Trial outcomes

Primary outcomes

1

Endogenous thrombin potential (ETP)

Thrombin generation profiles will be assessed in whole blood, plasma, and platelet-rich plasma. Endogenous thrombin potential will be compared between patients with sickle cell disease and an SS genotype and patients with sickle cell disease and an SC genotype

Time frame
At baseline

Secondary outcomes

1

Lag time of thrombin generation

Thrombin generation will be assessed in whole blood, plasma, and platelet-rich plasma. Lag time will be compared between patients with sickle cell disease and the HbSS genotype and those with the HbSC genotype.

Time frame
At baseline
2

Time to peak thrombin generation

Thrombin generation will be assessed in whole blood, plasma, and platelet-rich plasma. Time to peak will be compared between patients with sickle cell disease and the HbSS genotype and those with the HbSC genotype.

Time frame
At baseline
3

Peak height of thrombin generation

Thrombin generation will be assessed in whole blood, plasma, and platelet-rich plasma. Peak height will be compared between patients with sickle cell disease and the HbSS genotype and those with the HbSC genotype.

Time frame
At baseline
4

Platelet activation profile

Platelet activation profiles will be assessed and compared between patients with sickle cell disease and the HbSS genotype and those with the HbSC genotype.

Time frame
At baseline

Other outcomes

Sponsors and contacts

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