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

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.

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Key information

Conditions

Sickle Cell Disease (SCD) Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Hemolysis Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Insitut Hématologique et Oncologique Pédiatrique (IHOPe), Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

3 additional citrate tubes (2.7mL)

Primary outcomes

Overall coagulation activity

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Corine Halfon-Domenech, Dr

CONTACT

[email protected]

0033469166550 ext. +33

Philippe CONNES, Pr

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424

Registry information

Acronym: DREPA COAG

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Oct 1, 2024
Registry last updated: Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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