Dense Red Blood Cells in Sickle Cell Children

Sickle Cell Disease Clinical Trial

— DREPADENSE  

Official title:

Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02887118
• Other study ID #: DREPADENSE
• Status: Terminated
• Start date: December 2015
• Est. completion date: July 7, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: July 7, 2019
• Est. primary completion date: July 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
France	CHI Creteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

References & Publications (7)

Bartolucci P, Brugnara C, Teixeira-Pinto A, Pissard S, Moradkhani K, Jouault H, Galacteros F. Erythrocyte density in sickle cell syndromes is associated with specific clinical manifestations and hemolysis. Blood. 2012 Oct 11;120(15):3136-41. doi: 10.1182/blood-2012-04-424184. Epub 2012 Aug 23. Erratum in: Blood. 2014 Mar 20;123(12):1972. — View Citation

Benkerrou M, Alberti C, Couque N, Haouari Z, Ba A, Missud F, Boizeau P, Holvoet L, Ithier G, Elion J, Baruchel A, Ducrocq R. Impact of glucose-6-phosphate dehydrogenase deficiency on sickle cell anaemia expression in infancy and early childhood: a prospective study. Br J Haematol. 2013 Dec;163(5):646-54. doi: 10.1111/bjh.12590. Epub 2013 Oct 10. — View Citation

Bernaudin F, Verlhac S, Arnaud C, Kamdem A, Chevret S, Hau I, Coïc L, Leveillé E, Lemarchand E, Lesprit E, Abadie I, Medejel N, Madhi F, Lemerle S, Biscardi S, Bardakdjian J, Galactéros F, Torres M, Kuentz M, Ferry C, Socié G, Reinert P, Delacourt C. Impact of early transcranial Doppler screening and intensive therapy on cerebral vasculopathy outcome in a newborn sickle cell anemia cohort. Blood. 2011 Jan 27;117(4):1130-40; quiz 1436. doi: 10.1182/blood-2010-06-293514. Epub 2010 Nov 10. — View Citation

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. — View Citation

Quinn CT, Shull EP, Ahmad N, Lee NJ, Rogers ZR, Buchanan GR. Prognostic significance of early vaso-occlusive complications in children with sickle cell anemia. Blood. 2007 Jan 1;109(1):40-5. Epub 2006 Aug 29. — View 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. Erratum in: Blood. 2016 Dec 15;128(24):2869. — View Citation

Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517. Review. Erratum in: JAMA. 2014 Nov 12;312(18):1932. JAMA. 2015 Feb 17;313(7):729. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of dense red blood cells (DRBC)	Evaluation of the number of dense red blood cells in the blood of affected children	1 day
Secondary	biological profile	hemolytic parameters (LDH, bilirubin, Hemoglobin level)	1 day
Secondary	Number of patients with velocities > 200 cm/sec on transcranial doppler	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)	1 day
Secondary	Number of patients with history of acute splenic sequestration,		1 day
Secondary	Number of patients with history of acute chest syndrome		1 day
Secondary	Number of patients with History of dactylitis		1 day
Secondary	Number of patients with history of abnormal transcranial doppler (TCD) (= 200 cm/sec)		1 day
Secondary	Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI)		1 day
Secondary	Number of patients with hydroxycarbamide treatment	effect of hydroxycarbamide on the % DRBC	1 day
Secondary	Number of dense red blood cells	number of dense red blood cells in the pediatric population with no known blood condition	1 day