Evaluation of the Impact of Red Blood Cell Exchange on Thrombo-inflammation in Sickle Cell Disease

NCT06769139 | Not Yet Recruiting

• 1 other identifier: RC31/24/0509
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Sickle cell disease is the most common inherited blood disorder worldwide. It is a hemoglobinopathy characterized by chronic hemolysis, endotheliopathy, coagulation activation, and chronic inflammation. It is a multisystemic disease leading to acute (vaso-occlusive crisis, acute chest syndrome, stroke…) and chronic complications with multiorgan damage. Thrombo-inflammation is defined by the cooperation and interaction between hemostasis and the innate immune system. The platelet represents the cornerstone of this phenomenon, being at the interface of these two systems. In sickle cell disease, platelets are activated and release cytokines, leading to a pro-coagulant and pro-inflammatory state. Transfusion, whether occasional or chronic, is a major sickle cell disease treatment. It is common to distinguish simple transfusion from exchange transfusion. The latter involves replacing a given volume of sickle red blood cells with healthy red blood cells. Exchange transfusion allows avoiding an excessive increase in hemoglobin. The decrease of hemoglobin S under 30% achieved by red blood cell exchange reduces the risk of stroke by more than 90% in children with cerebral vasculopathy. Moreover, transfusion can be used in acute complications such as vaso-occlusive crisis and acute chest syndrome. Despite this efficacy, a subgroup of patients is not totally protected against acute and chronic complications. The persistence of chronic inflammation is suggested. To date, it is not known if red blood cell exchange can reduce the thrombo-inflammatory dynamic in sickle cell disease. The aim of this study is to evaluate the impact of red blood cell exchange on thrombo-inflammatory parameters in 20 adult sickle cell patients (10 patients on manual exchange and 10 patients on automatized exchange).

Conditions

Sickle Cell Disease

Keywords

thrombo-inflammation; Red blood cell Exchange

Outcome Measures

Primary Outcomes (1)

• Evaluation of thrombo-inflammation parameters in sickle patients treated by red blood cell exchange

  Thrombo-inflammation is evaluate using a composite criteria composed by 4 thromo-inflammatory parameters : soluble platelet activation markers, inflammasome, platelet response, circulating platelet microparticles and lipidomic study of plasma eicosanoids.

  2 days

Study Arms (1)

Sickle patients treated by red blood cell exchange

20 adult sickle cell patients treated by red blood cell exchange (10 patients on manual exchange and 10 patients on automatized exchange)

Other: Red blood cell exchange

Interventions

Red blood cell exchange OTHER

Red blood cell exchange manual exchange and automatized exchange

Sickle patients treated by red blood cell exchange

Eligibility Criteria

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

Study Population

Patients will be identified during a follow-up consultation in the internal medicine department.

You may qualify if:

• Sickled Cell Disease patient with SS or S/beta thalassemia genotype
• Red blood cell exchange \> 3 months
• Up-to-date social security coverage
• Patient able to understand the purpose and constraints of the research project
• Patient has read the study information leaflet and does not object to the research.

You may not qualify if:

• Thrombopenia \< 50 G/L
• Non-steroidal anti-inflammatory drugs \< 7 days before enrolment
• Anti-platelet agents \< 7 days before enrolment
• Pregnancy or breastfeeding
• Patient objects to take part in the study
• Patient under guardianship, curatorship or safeguard of justice
• Patients with ongoing clinical trial requiring collection of additional blood samples

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Etablissement Français du Sang: collaborator

Study Sites (1)

Oncopole - Toulouse Hospital

Toulouse, 31059, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Anemia, Sickle Cell

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

Study Officials

• Pierre COUGOUL, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre COUGOUL, MD

CONTACT

0531156265; cougoul.pierre@iuct-oncopole.fr

Study Design

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

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

FR (1)