Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- number of dense red blood cells (DRBC)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
number of dense red blood cells (DRBC)
Time Frame: 1 day
Evaluation of the number of dense red blood cells in the blood of affected children
Secondary Outcomes
- biological profile(1 day)
- Number of patients with velocities > 200 cm/sec on transcranial doppler(1 day)
- Number of patients with history of acute splenic sequestration,(1 day)
- Number of patients with history of acute chest syndrome(1 day)
- Number of patients with History of dactylitis(1 day)
- Number of patients with history of abnormal transcranial doppler (TCD) (≥ 200 cm/sec)(1 day)
- Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI)(1 day)
- Number of patients with hydroxycarbamide treatment(1 day)
- Number of dense red blood cells(1 day)
Investigators
Corinne Pondarré
Doctor
Centre Hospitalier Intercommunal Creteil