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

NCT06619093 | Not Yet Recruiting

• 1 other identifier: 69HCL24_0679
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Disease (SCD)

Keywords

Hemolysis; Coagulation; Red blood cell; Sickle cell disease

Outcome Measures

Primary Outcomes (1)

• Overall coagulation activity

  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.

  Baseline

Study Arms (2)

High hemolytic group

Lactate Dehydrogenase Level \> 484 IU/L

Other: blood sampling

Low hemolytic group

Lactacte Dehydrogenase Level less or equal to 484 IU/L

Other: blood sampling

Interventions

blood sampling OTHER

3 additional citrate tubes (2.7mL)

High hemolytic group; Low hemolytic group

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sickle cell disease, followed regularly by the Sickle Cell Center of Lyon Hospitals (Hospices Civils de Lyon).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424: collaborator

Study Sites (2)

Insitut Hématologique et Oncologique Pédiatrique (IHOPe)

Lyon, 69008, France

Location

Service de Médecine Interne - Hôpital Edouard Herriot

Lyon, 69008, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Hemolysis; Thrombosis

Interventions

Blood Specimen Collection

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Corine Halfon-Domenech, Dr

CONTACT

0033469166550; Carine.HALFONDOMENECH@ihope.fr

Philippe CONNES, Pr

CONTACT

philippe.connes@univ-lyon1.fr

Study Design

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

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

FR (2)