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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8+
SponsorHospices Civils de Lyon

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • blood sampling

    Other intervention

    3 additional citrate tubes (2.7mL)

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: High hemolytic group1 intervention
Group B: Low hemolytic group1 intervention

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424

Collaborator

This trial is not recruiting at the moment. You can still explore other options: