- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02887118
Dense Red Blood Cells in Sickle Cell Children (DREPADENSE)
Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Créteil, Frankrig, 94000
- CHI Creteil
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
number of dense red blood cells (DRBC)
Tidsramme: 1 day
|
Evaluation of the number of dense red blood cells in the blood of affected children
|
1 day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
biological profile
Tidsramme: 1 day
|
hemolytic parameters (LDH, bilirubin, Hemoglobin level)
|
1 day
|
Number of patients with velocities > 200 cm/sec on transcranial doppler
Tidsramme: 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) |
1 day
|
Number of patients with history of acute splenic sequestration,
Tidsramme: 1 day
|
1 day
|
|
Number of patients with history of acute chest syndrome
Tidsramme: 1 day
|
1 day
|
|
Number of patients with History of dactylitis
Tidsramme: 1 day
|
1 day
|
|
Number of patients with history of abnormal transcranial doppler (TCD) (≥ 200 cm/sec)
Tidsramme: 1 day
|
1 day
|
|
Number of patients with history of ischemic lesions on magnetic resonance imaging (MRI)
Tidsramme: 1 day
|
1 day
|
|
Number of patients with hydroxycarbamide treatment
Tidsramme: 1 day
|
effect of hydroxycarbamide on the % DRBC
|
1 day
|
Number of dense red blood cells
Tidsramme: 1 day
|
number of dense red blood cells in the pediatric population with no known blood condition
|
1 day
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Corinne Pondarre, MD PhD, CHI Creteil
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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. Erratum In: JAMA. 2014 Nov 12;312(18):1932. JAMA. 2015 Feb 17;313(7):729.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DREPADENSE
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Seglcellesygdom
-
Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
-
University of BolognaNovartisUkendtMyeloproliferative lidelser | Hypereosinofilt syndrom | Kronisk eosinofil leukæmi (CEL)Italien
-
AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
-
Novartis PharmaceuticalsAfsluttetKronisk myeloid leukæmi (CML) | Philadelphia kromosom positiv akut lymfoblastisk leukæmi (Ph+ ALL) | Andre Glivec/Gleevec-indicerede hæmatologiske lidelser (HES, CEL, MDS/MPN)Den Russiske Føderation