跳至主要内容
临床试验/NCT05646888
NCT05646888进行中(未招募)不适用

Inflammation, Platelets and Sickle Cell Disease

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年1月15日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25
试验地点
1
主要终点
To evaluate mechanisms of platelet activation in the thrombo-inflammation process during a vaso-occlusive crisis.

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

时间窗: First 48h of hospitalization

by flow cytometry analysis

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

时间窗: Day 13 (+/- 2 days)

by flow cytometry analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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