Inflammation, Platelets and Sickle Cell Disease

NCT05646888 | Active Not Recruiting

• 1 other identifier: RC31/22/0255
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Sickle cell disease (SCD) is an autosomal recessive genetic disorder linked to a single mutation on beta-globin chains. This leads to red blood cell deformation and chronic hemolysis which can result in vaso-occlusive events, anemia and vasculopathy. Pathophysiology is incompletely understood, and beyond red blood cell's abnormalities this involves hemostasis and innate immunity. The aim of our study is to describe the mechanisms of thrombo-inflammation during the vaso-occlusive crisis (VOC) in adults with sickle cell disease.

Conditions

Platelet Activation; Thromboinflammation; Sickle Cell Disease

Keywords

Sickle cell disease; vaso-occlusive crisis; platelets; thrombo-inflammation

Outcome Measures

Primary Outcomes (3)

• To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.

  by flow cytometry analysis

  First 48h of hospitalization

• To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.

  by flow cytometry analysis

  Day 13 (+/- 2 days)

• To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.

  by flow cytometry analysis

  At day 60 (+/- 2 days)

Interventions

Blood sampling BIOLOGICAL

the blood sample will be taken during a planned blood sampling

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sickle cell disease diagnosis

You may qualify if:

• Patient with sickle cell disease diagnosis, hospitalized in emergency department and/or internal medicine department
• Patient older than 18 years
• Written consent to participate to the study
• Patient with health insurance
• Patient able to receive information about the study

You may not qualify if:

• Age \< 18 years
• Non consent to participate to the study
• Women in pregnancy or breastfeeding
• Treatment with aspirin or non steroidal anti inflammatory drug
• Protected patient
• Patient already involved in a study requiring collection of additional biological samples

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

IUCT-Oncopole University Hospital

Toulouse, 31500, France

Location

MeSH Terms

Conditions

Thromboinflammation; Anemia, Sickle Cell; Vaso-Occlusive Crises

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre Cougoul, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: December 12, 2022
• Study Start: January 15, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)