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

NCT07852442 | Not Yet Recruiting

• 1 other identifier: CHUG_RIPH2_2026/01
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Venous Thromboembolism; Sickle Cell Disease

Keywords

Sickle cell disease; thrombin generation; platelet activation; aggregometry; platelets

Outcome Measures

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

  At baseline

Secondary Outcomes (5)

• Lag time of thrombin generation

  At baseline

• Time to peak thrombin generation

  At baseline

• Peak height of thrombin generation

  At baseline

• Platelet activation profile

  At baseline

• Platelet aggregation profile

  At baseline

Study Arms (2)

SS Group

Patients with sickle cell disease and an SS genotype.

SC Group

Patients with sickle cell disease and an SC genotype.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• SCD patients with SS or SC
• diagnosis of SCD performed by electrophoresis or high-performance liquid chromatography (HPLC) in a reference laboratory for hemoglobinopathies
• patient followed up for SCD at the sickle cell center of Guadeloupe (University hospital of Guadeloupe, Pointe à Pitre) or at the Adult Rare Diseases Reference Center "Sickle Cell Disease / Major Sickle Cell Syndromes" of the Avicenne hospital in Bobigny.
• patients who will provide written informed consent in accordance with the Declaration of Helsinki
• patients affiliated with national social security

You may not qualify if:

• 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
• pregnant or breastfeeding patients

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead
• Hospital Avicenne: collaborator

Study Sites (2)

Hôpital Avicenne

Bobigny, 93000, France

Location

CHU de la Guadeloupe

Les Abymes, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Véronique Baccini, MD PhD

  chu de la guadeloupe

  STUDY DIRECTOR

• Sylvain Lejeune, MD PhD

  Centre de Référence Maladies Rares Adulte de Bobigny " Drépanocytose / syndromes drépanocytaires majeurs " de l'hôpital Avicenne

  PRINCIPAL INVESTIGATOR

• Maryse ETIENNE JULAN, MD

  CHU de la Guadeloupe Coordonnateur, Centre de référence des syndromes drépanocytaires majeurs, thalassémies et autres pathologies rares du globule rouge et de l'érythropoïèse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mélanie petapermal, Master degree

CONTACT

0590934667; melanie.petapermal@chu-guadeloupe.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): October 15, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GU (1)