Dense Red Blood Cells in Sickle Cell Children

NCT02887118 | Terminated

• 1 other identifier: DREPADENSE
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sickle Cell Disease

Keywords

Erythrocytes; Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (1)

Common arm

Children with sickle cell anemia will be included. Blood samples of all the included patients will be collected during a day-hospitalization for a planned chek-up. For all these patients the number of dense erythrocytes will be evaluated

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

CHI Creteil

Créteil, 94000, France

Location

Related Publications (7)

• 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.

  PMID: 10631276 BACKGROUND

• 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.

  PMID: 24117340 BACKGROUND

• 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. doi: 10.1182/blood-2006-02-005082. Epub 2006 Aug 29.

  PMID: 16940426 BACKGROUND

• Bernaudin F, Verlhac S, Arnaud C, Kamdem A, Chevret S, Hau I, Coic L, Leveille E, Lemarchand E, Lesprit E, Abadie I, Medejel N, Madhi F, Lemerle S, Biscardi S, Bardakdjian J, Galacteros F, Torres M, Kuentz M, Ferry C, Socie 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.

  PMID: 21068435 BACKGROUND

• 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.

  PMID: 22919030 BACKGROUND

• 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.

  PMID: 22915643 BACKGROUND

• 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.

  PMID: 25203083 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples to study dense red blood cells

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Corinne Pondarre, MD PhD

  CHI Créteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: September 1, 2016
• Study Start: December 1, 2015
• Primary Completion: July 7, 2019
• Study Completion: July 7, 2019
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)