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

Evaluation of the Impact of Red Blood Cell Exchange on Thrombo-inflammation in Sickle Cell Disease STIREX : Sickle Cell Disease - Thrombo-Inflammation - Red Blood Cell EXchange

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Other: Red blood cell exchange

Detailed Description

Prospective observational cohort with additional blood samples. This study is monocentric.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Pierre COUGOUL, MD; Phone Number: +33 0531156265; Email: cougoul.pierre@iuct-oncopole.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Oncopole - Toulouse Hospital
    • Contact: Pierre COUGOUL, MD
    • Contact: Pierre COUGOUL, MD; Phone Number: +33 0531156265; Email: cougoul.pierre@iuct-oncopole.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Red blood cell exchange manual exchange and automatized exchange

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Etablissement Français du Sang
• Investigators: Principal Investigator: Pierre Cougoul, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: thrombo-inflammation; Red blood cell Exchange
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Inflammation; Anemia, Sickle Cell
• Other Study ID Numbers: RC31/24/0509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No