Dense Red Blood Cells in Sickle Cell Children

Terminated

• Conditions: Sickle Cell Disease

• Registration Number: NCT02887118
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-01
• Primary Completion: 2019-07-07
• Study Completion: 2019-07-07
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of dense red blood cells (DRBC)	1 day	Evaluation of the number of dense red blood cells in the blood of affected children

Secondary Outcome Measures

Name	Time	Method
biological profile	1 day	hemolytic parameters (LDH, bilirubin, Hemoglobin level)
Number of patients with velocities > 200 cm/sec on transcranial doppler	1 day	Cerebral vasculopathy (correlation with patients with abnormal velocities on transcranial doppler (TCD)(\> 200 cm/sec); History of dactylitis History of ischemic lesions on magnetic resonance imaging (MRI)
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	effect of hydroxycarbamide on the % DRBC
Number of dense red blood cells	1 day	number of dense red blood cells in the pediatric population with no known blood condition

Trial Locations

Locations (1)

CHI Creteil; 🇫🇷 Créteil, France