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Clinical Trials/NCT04839159
NCT04839159UnknownNot Applicable

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 Hospital3 sites in 1 country41 target enrollmentStarted: May 10, 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
41
Locations
3
Primary Endpoint
Plasmatic levels of IL-6 at 12 months of age
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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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Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
6 Months to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

SCD Patient

Experimental

Intervention: Blood sampling (Other)

Outcomes

Primary Outcomes

Plasmatic levels of IL-6 at 12 months of age

Time Frame: 12 months of age

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

Secondary Outcomes

  • Plasmatic levels of IL-1ß at 2 years of age(2 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 E-selectine at 6 months of age(6 months of age)
  • Plasmatic levels of Factor VIII 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)
  • Plasmatic levels of IL-6 at 6 months of age(6 months 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 ICAM-1 at 2 years of age(2 years of age)
  • Plasmatic levels of ICAM-1 at 4 years of age(4 years 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-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 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 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 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-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 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 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 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)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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