Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation

NCT06619093 · tracked via the Priya Life Science France tracker

Sponsor

Hospices Civils de Lyon

Phase

Observational

Started

2025-02-01

Last updated

2025-01-15

Condition(s) studied

Sickle Cell Disease (SCD)

Investigational drug(s) / intervention(s)

blood sampling

blood sampling: 3 additional citrate tubes (2.7mL)

Study summary

Sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. The investigators hypothesized that patients with sickle cell disease and severe hemolysis (Lactate Dehydrogenase level \> 484 IU/L) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.

Eligibility

Sex

ALL

Min age

8 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Aged 8 years or older * Under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes S/S, S/beta0, or S/C * Patient covered by a social security or equivalent health insurance plan * Collection of the non-opposition for adults * Information of the minor and collection of the non-opposition from both parents Exclusion Criteria: * Patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion * Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator\'s discretion) * Patient under guardianship, curatorship, or legal protection * Patient subject to a legal protection measure * Person admitted to a health or social care institution for purposes other than research

Primary outcome measure(s)

Overall coagulation activity — Baseline
To compare the overall coagulation activity (measurement of in vitro clot formation by rotary thromboelastometry (ROTEM)) between sickle cell patients with a severe haemolytic phenotype and those with a less severe haemolytic phenotype.

Trial sites (2)

Facility	City	Region	Status
Insitut Hématologique et Oncologique Pédiatrique (IHOPe)	Lyon	France
Service de Médecine Interne - Hôpital Edouard Herriot	Lyon	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619093 on ClinicalTrials.gov ↗ ← All trials in France