Il-Padre: Inflammation, Platelets and Sickle Cell Disease

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05646888

Collaborator

(none)

Enrollment

Location

5.5

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Activation Thromboinflammation Sickle Cell Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Inflammation, Platelets and Sickle Cell Disease

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Outcome Measures

Primary Outcome Measures

To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis. [First 48h of hospitalization]
by flow cytometry analysis
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis. [Day 13 (+/- 2 days)]
by flow cytometry analysis
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis. [At day 60 (+/- 2 days)]
by flow cytometry analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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