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Not yet recruiting NCT06619093

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

Observational Sickle Cell Disease (SCD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sampling.
Who it may be relevant to
Registry conditions: Sickle Cell Disease (SCD). Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other blood sampling
    3 additional citrate tubes (2.7mL)

Primary outcome measures

  • Overall coagulation activity [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Insitut Hématologique et Oncologique Pédiatrique (IHOPe) — Lyon
  • Service de Médecine Interne - Hôpital Edouard Herriot — Lyon

Identifiers

NCT: NCT06619093 · 69HCL24_0679

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗