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Clinical Trials/NCT05646888
NCT05646888Active, not recruitingNot Applicable

Inflammation, Platelets and Sickle Cell Disease

University Hospital, Toulouse1 site in 1 country25 target enrollmentStarted: January 15, 2023Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
25
Locations
1
Primary Endpoint
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.

Study Overview

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.

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
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: At day 60 (+/- 2 days)

by flow cytometry analysis

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

Time Frame: First 48h of hospitalization

by flow cytometry analysis

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

Time Frame: Day 13 (+/- 2 days)

by flow cytometry analysis

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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