Clinical trial NCT02887118: Dense Red Blood Cells in Sickle Cell Children
Official title: Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sickle Cell Disease
Keywords: Erythrocytes
Sickle Cell Disease
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with sickle cell disease followed regularly in the CHI creteil hospital aged from 18 months to 18 years old.

Brief summary: Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort.

Detailed description: An association between red blood cell density and hemolytic parameters, and clinical manifestations has been demonstrated in adults with sickle cell anemia.

This factor has not been studied in children. The identification of predictive biomarkers of disease severity, especially of specific pediatric complications (cerebral vasculopathy, splenic sequestration, Dactylitis) would be useful for optimal care of the children and early intensification Red blood cell density might be one of these prognostic factors.

Eligibility criteria: Inclusion Criteria:

* Age: 18 months-18 years
* Patient with sickle cell disease namely SS, or S / Beta0 or S / Beta +
* Patient regularly followed in the pediatric cohort of the CHI Creteil
* Patient Hospitalized for an annual check-up
* With or without intensification by Hydroxycarbamide
* patient who haven't been transfused within 3 months
* Whose parents have given their informed consent
* Patients insured to the French social scheme

Exclusion Criteria:

* Sickle cell SC disease
* Having received an allogeneic bone marrow transplantation
* Under regular transfusion program
* Having received a transfusion within 3 months

Primary outcomes:
measure: number of dense red blood cells (DRBC)
timeFrame: 1 day
Secondary outcomes:
measure: biological profile
timeFrame: 1 day
measure: Number of patients with velocities > 200 cm/sec on transcranial doppler
timeFrame: 1 day
measure: Number of patients with history of acute splenic sequestration,
timeFrame: 1 day
measure: Number of patients with history of acute chest syndrome
timeFrame: 1 day
measure: Number of patients with History of dactylitis
timeFrame: 1 day
measure: Number of patients with history of abnormal transcranial doppler (TCD) (≥ 200 cm/sec)
timeFrame: 1 day
measure: Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI)
timeFrame: 1 day
measure: Number of patients with hydroxycarbamide treatment
timeFrame: 1 day
measure: Number of dense red blood cells
timeFrame: 1 day
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Creteil
Study officials:
affiliation: CHI Créteil
name: Corinne Pondarre, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Thornburg CD, Files BA, Luo Z, Miller ST, Kalpatthi R, Iyer R, Seaman P, Lebensburger J, Alvarez O, Thompson B, Ware RE, Wang WC; BABY HUG Investigators. Impact of hydroxyurea on clinical events in the BABY HUG trial. Blood. 2012 Nov 22;120(22):4304-10; quiz 4448. doi: 10.1182/blood-2012-03-419879. Epub 2012 Aug 22.
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