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临床试验/NCT04839159
NCT04839159Unknown不适用

Prospective Clinical Study on Early Inflammatory, Cell Adhesion and Hemostatic Plasmatic Markers of Endothelial Dysfunction in Children With Sickle Cell Disease (SCD)

Queen Fabiola Children's University Hospital6 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2012年5月10日最近更新:
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适应症

试验速览

阶段
不适用
入组人数
41
试验地点
6
主要终点
Plasmatic levels of IL-6 at 12 months of age
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Sickle cell disease is associated with significant morbi-mortality hence the interest in an early and targeted care. At present, there is no plasmatic marker able to identify infants at higher risk of developping severe complications later in life. However, recent studies have demonstrated a correlation between certain complications of the disease and biomarkers of the endothelial dysfunction characterizing it.

Investigators prospectively followed a cohort of children diagnosed with SCD through the universal neonatal screening using inflammatory and haemostatic plasmatic markers to study their annual evolution. Investigators then will evaluate potential associations between these biological markers and the occurrence of SCD related complications. A secondary objective of this study is to evaluate the repercussions of therapeutic intervention on these markers.

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研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Months 至 —（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patient aged less than 6 months
  • •Sickle cell syndrome SS, Sβthal or SC confirmed by hemoglobin electrophoresis
  • •Subjects legal representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to let participate their child in the study

排除标准

  • •Congenital abnormality other than sickle cell disease except for a glucose-6-phosphate-deshydrogenase
  • •Prematurity
  • •Initiation of the following therapies before enrollment: chronic transfusion regimen or bone marrow transplantation

结局指标

主要结局

Plasmatic levels of IL-6 at 12 months of age

时间窗: 12 months of age

Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay

次要结局

  • Plasmatic levels of IL-1ß at 2 years of age(2 years of age)
  • Plasmatic levels of ICAM-1 at 2 years of age(2 years of age)
  • Plasmatic levels of IL-6 at 6 months of age(6 months of age)
  • Plasmatic levels of ICAM-1 at 4 years of age(4 years of age)
  • Plasmatic levels of IL-6 at 2 years of age(2 years of age)
  • Plasmatic levels of IL-8 at 12 months of age(12 months of age)
  • Plasmatic levels of IL-10 at 2 years of age(2 years of age)
  • Plasmatic levels of IL-12 at 12 months of age(12 months of age)
  • Plasmatic levels of IL-12 at 4 years of age(4 years of age)
  • Plasmatic levels of IL-12 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of TNF alpha at 3 years of age(3 years of age)
  • Plasmatic levels of TNF alpha at 4 years of age(4 years of age)
  • Plasmatic levels of ICAM-1 at 6 months of age(6 months of age)
  • Plasmatic levels of VCAM-1 at 3 years of age(3 years of age)
  • Plasmatic levels of IL-6 at 3 years of age(3 years of age)
  • Plasmatic levels of IL-6 at 4 years of age(4 years of age)
  • Plasmatic levels of IL-1ß at 6 months of age(6 months of age)
  • Plasmatic levels of IL-1ß at 4 years of age(4 years of age)
  • Plasmatic levels of IL-6 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of IL-1ß at 12 months of age(12 months of age)
  • Plasmatic levels of IL-1ß at 3 years of age(3 years of age)
  • Plasmatic levels of IL-10 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 12 months of age(12 months of age)
  • Plasmatic levels of IL-10 at 6 months of age(6 months of age)
  • Plasmatic levels of IL-8 at 6 months of age(6 months of age)
  • Plasmatic levels of IL-8 at 2 years of age(2 years of age)
  • Plasmatic levels of IL-8 at 4 years of age(4 years of age)
  • Plasmatic levels of IL-10 at 12 months of age(12 months of age)
  • Plasmatic levels of IL-12 at 6 months of age(6 months of age)
  • Plasmatic levels of IL-12 at 3 years of age(3 years of age)
  • Plasmatic levels of ICAM-1 at 12 months of age(12 months of age)
  • Plasmatic levels of VCAM-1 at 2 years of age(2 years of age)
  • Plasmatic levels of ICAM-1 at 3 years of age(3 years of age)
  • Plasmatic levels of VCAM-1 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of IL-1ß before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of IL-8 at 3 years of age(3 years of age)
  • Plasmatic levels of IL-10 at 4 years of age(4 years of age)
  • Plasmatic levels of IL-12 at 2 years of age(2 years of age)
  • Plasmatic levels of TNF alpha at 2 years of age(2 years of age)
  • Plasmatic levels of E-selectine at 6 months of age(6 months of age)
  • Plasmatic levels of IL-8 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of IL-10 at 3 years of age(3 years of age)
  • Plasmatic levels of TNF alpha at 6 months of age(6 months of age)
  • Plasmatic levels of TNF alpha before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of VCAM-1 at 12 months of age(12 months of age)
  • Plasmatic levels of TNF alpha at 12 months of age(12 months of age)
  • Plasmatic levels of ICAM-1 before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of VCAM-1 at 6 months of age(6 months of age)
  • Plasmatic levels of E-selectine at 12 months of age(12 months of age)
  • Plasmatic levels of E-selectine before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of P-selectine before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 2 years of age(2 years of age)
  • Endogenous thrombin potential parameter in thrombin generation assay before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of Factor VIII at 12 months of age(12 months of age)
  • Plasmatic levels of P-selectine at 6 months of age(6 months of age)
  • Plasmatic levels of P-selectine at 3 years of age(3 years of age)
  • Plasmatic levels of P-selectine at 4 years of age(4 years of age)
  • Plasmatic levels of VCAM-1 at 4 years of age(4 years of age)
  • Plasmatic levels of E-selectine at 2 years of age(2 years of age)
  • Plasmatic levels of E-selectine at 3 years of age(3 years of age)
  • Plasmatic levels of E-selectine at 4 years of age(4 years of age)
  • Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 6 months of age(6 months of age)
  • Plasmatic levels of VEGF before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Peak height parameter in thrombin generation assay at 2 years of age(2 years of age)
  • Time to peak parameter in thrombin generation assay at 12 months of age(12 months of age)
  • Time to peak parameter in thrombin generation assay before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Plasmatic levels of Factor VIII at 3 years of age(3 years of age)
  • Plasmatic levels of P-selectine at 12 months of age(12 months of age)
  • Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 3 years of age(3 years of age)
  • Lag time parameter in thrombin generation assay at 6 months of age(6 months of age)
  • Lag time parameter in thrombin generation assay at 12 months of age(12 months of age)
  • Lag time parameter in thrombin generation assay at 3 years of age(3 years of age)
  • Peak height parameter in thrombin generation assay at 12 months of age(12 months of age)
  • Peak height parameter in thrombin generation assay at 3 years of age(3 years of age)
  • Peak height parameter in thrombin generation assay at 4 years of age(4 years of age)
  • Peak height parameter in thrombin generation assay before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Time to peak parameter in thrombin generation assay at 6 months of age(6 months of age)
  • Time to peak parameter in thrombin generation assay at 4 years of age(4 years of age)
  • Endogenous thrombin potential parameter in thrombin generation assay at 2 years of age(2 years of age)
  • Plasmatic VCAM-1 levels after in vitro stimulation with LPS(Plasmatic level of VCAM-1 after in vitro stimulation with LPS)
  • Plasmatic levels of P-selectine at 2 years of age(2 years of age)
  • Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 4 years of age(4 years of age)
  • Lag time parameter in thrombin generation assay before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)
  • Endogenous thrombin potential parameter in thrombin generation assay at 6 months of age(6 months of age)
  • Lag time parameter in thrombin generation assay at 2 years of age(2 years of age)
  • Lag time parameter in thrombin generation assay at 4 years of age(4 years of age)
  • Peak height parameter in thrombin generation assay at 6 months of age(6 months of age)
  • Time to peak parameter in thrombin generation assay at 2 years of age(2 years of age)
  • Time to peak parameter in thrombin generation assay at 3 years of age(3 years of age)
  • Endogenous thrombin potential parameter in thrombin generation assay at 12 months of age(12 months of age)
  • Endogenous thrombin potential parameter in thrombin generation assay at 3 years of age(3 years of age)
  • Plasmatic levels of Factor VIII at 2 years of age(2 years of age)
  • Plasmatic levels of Factor VIII at 4 years of age(4 years of age)
  • Endogenous thrombin potential parameter in thrombin generation assay at 4 years of age(4 years of age)
  • Plasmatic levels of Factor VIII at 6 months of age(6 months of age)
  • Plasmatic levels of Factor VIII before the introduction of any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres(Before the introduction of any new sickle cell disease treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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