- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04839159
Study of Biological Markers in Children With Sickle Cell Disease
Prospective Clinical Study on Early Inflammatory, Cell Adhesion and Hemostatic Plasmatic Markers of Endothelial Dysfunction in Children With Sickle Cell Disease (SCD)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1020
- Hôpital Universitaire des Enfants Reine Fabiola
-
Brussels, Belgium, 1000
- CHU Saint Pierre
-
Brussels, Belgium, 1050
- HIS - Site Etterbeek-Ixelles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SCD Patient
|
Blood sampling at the age of 6 and 12 months, 2-3-4 years
Blood sampling before any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasmatic levels of IL-6 at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of IL-6 at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of IL-6 at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of IL-6 at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
|
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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of IL-6 (fg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of IL-1ß at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of IL-1ß at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of IL-1ß at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of IL-1ß at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of IL-1ß at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
|
4 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of IL-1ß (fg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of IL-8 at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of IL-8 at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of IL-8 at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of IL-8 at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of IL-8 at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
|
4 years 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of IL-8 (fg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of IL-10 at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of IL-10 at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of IL-10 at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of IL-10 at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of IL-10 at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
|
4 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of IL-10 (fg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of IL-12 at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of IL-12 at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of IL-12 at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of IL-12 at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of IL-12 at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
|
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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of IL-12 (fg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of TNF alpha at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of TNF alpha at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of TNF alpha at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of TNF alpha at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of TNF alpha at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
|
4 years 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of TNF alpha (fg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of ICAM-1 at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of ICAM-1 at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of ICAM-1 at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of ICAM-1 at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of ICAM-1 at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
|
4 years 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of ICAM-1 (pg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of VCAM-1 at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of VCAM-1 at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of VCAM-1 at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of VCAM-1 at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of VCAM-1 at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
|
4 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic VCAM-1 levels after in vitro stimulation with LPS
Time Frame: Plasmatic level of VCAM-1 after in vitro stimulation with LPS
|
Measurement of plasmatic levels of VCAM-1 (pg/mL) by flow cytometric assay after in vitro stimulation with LPS
|
Plasmatic level of VCAM-1 after in vitro stimulation with LPS
|
Plasmatic levels of E-selectine at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of E-selectine at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of E-selectine at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of E-selectine at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of E-selectine at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
|
4 years 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of E-selectine (pg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of P-selectine at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of P-selectine at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of P-selectine at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of P-selectine at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of P-selectine at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
|
4 years of age
|
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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of P-selectine (pg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
|
6 months of age
|
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
|
12 months of age
|
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
|
2 years of age
|
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
|
3 years of age
|
Plasmatic levels of Vascular Endothelial Growth Factor (VEGF) at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
|
4 years 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of VEGF (pg/mL) by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Lag time parameter in thrombin generation assay at 6 months of age
Time Frame: 6 months of age
|
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
6 months of age
|
Lag time parameter in thrombin generation assay at 12 months of age
Time Frame: 12 months of age
|
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
12 months of age
|
Lag time parameter in thrombin generation assay at 2 years of age
Time Frame: 2 years of age
|
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
2 years of age
|
Lag time parameter in thrombin generation assay at 3 years of age
Time Frame: 3 years of age
|
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
3 years of age
|
Lag time parameter in thrombin generation assay at 4 years of age
Time Frame: 4 years of age
|
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of lag time (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
Before the introduction of any new sickle cell disease treatment
|
Peak height parameter in thrombin generation assay at 6 months of age
Time Frame: 6 months of age
|
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
6 months of age
|
Peak height parameter in thrombin generation assay at 12 months of age
Time Frame: 12 months of age
|
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
12 months of age
|
Peak height parameter in thrombin generation assay at 2 years of age
Time Frame: 2 years of age
|
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
2 years of age
|
Peak height parameter in thrombin generation assay at 3 years of age
Time Frame: 3 years of age
|
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
3 years of age
|
Peak height parameter in thrombin generation assay at 4 years of age
Time Frame: 4 years of age
|
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of peak height (nM) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
Before the introduction of any new sickle cell disease treatment
|
Time to peak parameter in thrombin generation assay at 6 months of age
Time Frame: 6 months of age
|
Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
|
6 months of age
|
Time to peak parameter in thrombin generation assay at 12 months of age
Time Frame: 12 months of age
|
Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
|
12 months of age
|
Time to peak parameter in thrombin generation assay at 2 years of age
Time Frame: 2 years of age
|
Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
|
2 years of age
|
Time to peak parameter in thrombin generation assay at 3 years of age
Time Frame: 3 years of age
|
Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
|
3 years of age
|
Time to peak parameter in thrombin generation assay at 4 years of age
Time Frame: 4 years of age
|
Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
|
4 years 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of time to peak (minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method
|
Before the introduction of any new sickle cell disease treatment
|
Endogenous thrombin potential parameter in thrombin generation assay at 6 months of age
Time Frame: 6 months of age
|
Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
6 months of age
|
Endogenous thrombin potential parameter in thrombin generation assay at 12 months of age
Time Frame: 12 months of age
|
Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
12 months of age
|
Endogenous thrombin potential parameter in thrombin generation assay at 2 years of age
Time Frame: 2 years of age
|
Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
2 years of age
|
Endogenous thrombin potential parameter in thrombin generation assay at 3 years of age
Time Frame: 3 years of age
|
Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
3 years of age
|
Endogenous thrombin potential parameter in thrombin generation assay at 4 years of age
Time Frame: 4 years of age
|
Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
4 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
Time Frame: before the introduction of any new sickle cell disease treatment
|
Measurement of endogenous thrombin potential (nM x minutes) parameter of thrombin generation in platelet poor plasma using the Calibrated Automated Thrombogram (CAT®) method.
|
before the introduction of any new sickle cell disease treatment
|
Plasmatic levels of Factor VIII at 6 months of age
Time Frame: 6 months of age
|
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
|
6 months of age
|
Plasmatic levels of Factor VIII at 12 months of age
Time Frame: 12 months of age
|
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
|
12 months of age
|
Plasmatic levels of Factor VIII at 2 years of age
Time Frame: 2 years of age
|
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
|
2 years of age
|
Plasmatic levels of Factor VIII at 3 years of age
Time Frame: 3 years of age
|
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
|
3 years of age
|
Plasmatic levels of Factor VIII at 4 years of age
Time Frame: 4 years of age
|
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
|
4 years 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
Time Frame: Before the introduction of any new sickle cell disease treatment
|
Measurement of plasmatic levels of Factor VIII by flow cytometric assay
|
Before the introduction of any new sickle cell disease treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bushra Zucca, MD, Queen Fabiola Children's University Hospital
Publications and helpful links
General Publications
- Ware RE, de Montalembert M, Tshilolo L, Abboud MR. Sickle cell disease. Lancet. 2017 Jul 15;390(10091):311-323. doi: 10.1016/S0140-6736(17)30193-9. Epub 2017 Feb 1.
- Gulbis B, Cotton F, Ferster A, Ketelslegers O, Dresse MF, Ronge-Collard E, Minon JM, Le PQ, Vertongen F. Neonatal haemoglobinopathy screening in Belgium. J Clin Pathol. 2009 Jan;62(1):49-52. doi: 10.1136/jcp.2008.060517.
- Ballas SK, Lieff S, Benjamin LJ, Dampier CD, Heeney MM, Hoppe C, Johnson CS, Rogers ZR, Smith-Whitley K, Wang WC, Telen MJ; Investigators, Comprehensive Sickle Cell Centers. Definitions of the phenotypic manifestations of sickle cell disease. Am J Hematol. 2010 Jan;85(1):6-13. doi: 10.1002/ajh.21550.
- Horan J, Lerner N. Prediction of adverse outcomes in children with sickle cell disease. N Engl J Med. 2000 May 25;342(21):1612-3. doi: 10.1056/NEJM200005253422114. No abstract available.
- Miller ST, Sleeper LA, Pegelow CH, Enos LE, Wang WC, Weiner SJ, Wethers DL, Smith J, Kinney TR. Prediction of adverse outcomes in children with sickle cell disease. N Engl J Med. 2000 Jan 13;342(2):83-9. doi: 10.1056/NEJM200001133420203.
- Quinn CT, Lee NJ, Shull EP, Ahmad N, Rogers ZR, Buchanan GR. Prediction of adverse outcomes in children with sickle cell anemia: a study of the Dallas Newborn Cohort. Blood. 2008 Jan 15;111(2):544-8. doi: 10.1182/blood-2007-07-100719. Epub 2007 Oct 1.
- Gladwin MT, Vichinsky E. Pulmonary complications of sickle cell disease. N Engl J Med. 2008 Nov 20;359(21):2254-65. doi: 10.1056/NEJMra0804411. No abstract available.
- Charrin E, Ofori-Acquah SF, Nader E, Skinner S, Connes P, Pialoux V, Joly P, Martin C. Inflammatory and oxidative stress phenotypes in transgenic sickle cell mice. Blood Cells Mol Dis. 2016 Nov;62:13-21. doi: 10.1016/j.bcmd.2016.10.020. Epub 2016 Oct 28.
- Sarray S, Saleh LR, Lisa Saldanha F, Al-Habboubi HH, Mahdi N, Almawi WY. Serum IL-6, IL-10, and TNFalpha levels in pediatric sickle cell disease patients during vasoocclusive crisis and steady state condition. Cytokine. 2015 Mar;72(1):43-7. doi: 10.1016/j.cyto.2014.11.030. Epub 2015 Jan 5.
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Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2012/SCD1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sickle Cell Disease
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Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Hilton...CompletedSickle Cell Disease | Sickle Cell Anemia in Children | Sickle Cell Thalassemia | Sickle Cell SC DiseaseUnited States
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HemaQuest Pharmaceuticals Inc.TerminatedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Egypt, Canada, Jamaica
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HemaQuest Pharmaceuticals Inc.CompletedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Canada, Egypt, Jamaica
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