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

Not yet recruiting

• Conditions: Sickle Cell Disease (SCD)
• Interventions: Other: blood sampling

• Registration Number: NCT06619093
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-10-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Study Start: 2025-02-01
• Primary Completion: 2028-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High hemolytic group	blood sampling	Lactate Dehydrogenase Level \> 484 IU/L
Low hemolytic group	blood sampling	Lactacte Dehydrogenase Level less or equal to 484 IU/L

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (2)

Insitut Hématologique et Oncologique Pédiatrique (IHOPe); 🇫🇷 Lyon, France

Service de Médecine Interne - Hôpital Edouard Herriot; 🇫🇷 Lyon, France