Inflammation, Platelets and Sickle Cell Disease

Sickle Cell Disease Clinical Trial

— Il-Padre  

Official title:

Inflammation, Platelets and Sickle Cell Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646888
• Other study ID #: RC31/22/0255
• Status: Recruiting
• Start date: January 15, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2023
• Source: University Hospital, Toulouse
• Contact: Pierre Cougoul, MD
• Phone: 531156265
• Email: cougoul.pierre[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Inflammation
• Platelet Activation
• Sickle Cell Disease

Intervention

Biological:
• Blood sampling
the blood sample will be taken during a planned blood sampling

Locations

Country	Name	City	State
France	IUCT-Oncopole University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.	by flow cytometry analysis	First 48h of hospitalization
Primary	To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.	by flow cytometry analysis	Day 13 (+/- 2 days)
Primary	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)