Inflammation, Platelets and Sickle Cell Disease (Il-Padre)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sickle Cell Disease; Platelet Activation; Thromboinflammation
• Intervention / Treatment: Biological: Blood sampling

Detailed Description

Pathophysiology of sickle cell disease is incompletely understood. The typical change of red blood cells into sickle cells lead to post-capillary stream abnormalities. This phenomenon is responsible of ischemia-reperfusion injuries. Chronic hemolysis is the second part of the pathophysiology. The consequences are vasoconstriction, endothelial lesions, chronic inflammation, hemostasis and platelets activation. Thrombo-inflammation concept was proposed by Tanguay to describe the interactions between hemostasis, platelets and innate immune cells (neutrophils polynuclear) during thrombotic process. Since this time, this concept was largely described in many clinical situations such as septicemia, COVID-19, coronaropathy, auto-immune diseases and sickle cell disease.

In this project, we will study platelets activation and thrombo-inflammation markers in the beginning of a vaso-occlusive crisis, during the crisis and two months after the crisis. Blood samples will be collected during a routine care sample.

Biological markers studied will be:

• Soluble and surface markers of platelet activation; platelet-leukocytes aggregates
• Plasmatic eicosanoids produced by platelets (TXB2) and immune cells
• In vitro platelets reactivity; dynamic thrombus formation in normal and pathologic arterial blood stream
• Platelet's inflammasome

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31500
    • IUCT-Oncopole University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with sickle cell disease diagnosis

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Pierre Cougoul, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: vaso-occlusive crisis; platelets; Sickle cell disease; thrombo-inflammation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Genetic Diseases, Inborn; Inflammation; Hematologic Diseases; Embolism and Thrombosis; Blood Coagulation Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Thrombosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Thromboinflammation; Anemia, Sickle Cell; Vaso-Occlusive Crises; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: RC31/22/0255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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