Substudy of CADRE: for People With Extreme Phenotype: BIOCADRE

NCT03352986 | Unknown

• 1 other identifier: 003
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 2

Brief Summary

BIOCADRE is a CADRE substudy and aims to characterize more precisely the sickle cell patients with extreme phenotype.

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease; anemia; Africa

Outcome Measures

Primary Outcomes (1)

• Description of microcirculation by peripheral arterial tonometry

  EndoPAT2000®, Itamar Medical Ltd,

  1 year

Secondary Outcomes (7)

• Measure of blood viscosities

  1 year

• Dosage of microparticles

  1 year

• Determination of free hemoglobin

  1 year

• Measurement of neutrophil extracellular trap (NET)

  1 year

• Measurement of proinflammatory cytokines by ELISA

  1 year

Study Arms (6)

osteonecrosis

Sickle cell patients with osteonecrosis as a vascular main complication

Biological: biological analysis; Other: peripheral arterial tonometry

leg ulcer

Sickle cell patients with leg ulcer as a vascular main complication

Biological: biological analysis; Other: peripheral arterial tonometry

microalbuminuria

Sickle cell patients with microalbuminuria as a vascular main complication

Biological: biological analysis; Other: peripheral arterial tonometry

pulmonary hypertension

Sickle cell patients with pulmonary hypertension as a vascular main complication

Biological: biological analysis; Other: peripheral arterial tonometry

stroke

Sickle cell patients with strocke as a vascular main complication

Biological: biological analysis; Other: peripheral arterial tonometry

priapism

Sickle cell patients with priapism as a vascular main complication

Biological: biological analysis; Other: peripheral arterial tonometry

Interventions

biological analysis BIOLOGICAL

biological analysis will be performed in the 6 groups of patients

leg ulcer; microalbuminuria; osteonecrosis; priapism; pulmonary hypertension; stroke

peripheral arterial tonometry OTHER

peripheral arterial tonometry will be performed in the 6 groups of patients

leg ulcer; microalbuminuria; osteonecrosis; priapism; pulmonary hypertension; stroke

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is sickle cell patients with extreme phenotypes (SS-hemoglobin) with a steady state.

You may qualify if:

• sickle cell patients with extreme phenotypes: SS-hemoglobin

You may not qualify if:

• transfusion in the previous 2 months
• vaso-occlusive crisis in the previous 15 days
• infection in the previous 8 days

Sponsors & Collaborators

• Cardiologie et Développement: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Centre de Recherches er de Lutte contre la Drépanocytose

Bamako, Mali

RECRUITING

Centre National de Transfusion Sanguine

Dakar, Senegal

RECRUITING

Related Publications (25)

• Ranque B, Menet A, Diop IB, Thiam MM, Diallo D, Diop S, Diagne I, Sanogo I, Kingue S, Chelo D, Wamba G, Diarra M, Anzouan JB, N'Guetta R, Diakite CO, Traore Y, Legueun G, Deme-Ly I, Belinga S, Boidy K, Kamara I, Tharaux PL, Jouven X. Early renal damage in patients with sickle cell disease in sub-Saharan Africa: a multinational, prospective, cross-sectional study. Lancet Haematol. 2014 Nov;1(2):e64-73. doi: 10.1016/S2352-3026(14)00007-6. Epub 2014 Oct 28.

  PMID: 27030156 BACKGROUND

• Ranque B, Menet A, Boutouyrie P, Diop IB, Kingue S, Diarra M, N'Guetta R, Diallo D, Diop S, Diagne I, Sanogo I, Tolo A, Chelo D, Wamba G, Gonzalez JP, Abough'elie C, Diakite CO, Traore Y, Legueun G, Deme-Ly I, Faye BF, Seck M, Kouakou B, Kamara I, Le Jeune S, Jouven X. Arterial Stiffness Impairment in Sickle Cell Disease Associated With Chronic Vascular Complications: The Multinational African CADRE Study. Circulation. 2016 Sep 27;134(13):923-33. doi: 10.1161/CIRCULATIONAHA.115.021015. Epub 2016 Aug 31.

  PMID: 27582423 BACKGROUND

• Kato GJ, Gladwin MT, Steinberg MH. Deconstructing sickle cell disease: reappraisal of the role of hemolysis in the development of clinical subphenotypes. Blood Rev. 2007 Jan;21(1):37-47. doi: 10.1016/j.blre.2006.07.001. Epub 2006 Nov 7.

  PMID: 17084951 BACKGROUND

• Hebbel RP. Reconstructing sickle cell disease: a data-based analysis of the "hyperhemolysis paradigm" for pulmonary hypertension from the perspective of evidence-based medicine. Am J Hematol. 2011 Feb;86(2):123-54. doi: 10.1002/ajh.21952.

  PMID: 21264896 BACKGROUND

• Tharaux PL. Endothelin in renal injury due to sickle cell disease. Contrib Nephrol. 2011;172:185-199. doi: 10.1159/000328699. Epub 2011 Aug 30.

  PMID: 21893999 BACKGROUND

• Connes P, Lamarre Y, Hardy-Dessources MD, Lemonne N, Waltz X, Mougenel D, Mukisi-Mukaza M, Lalanne-Mistrih ML, Tarer V, Tressieres B, Etienne-Julan M, Romana M. Decreased hematocrit-to-viscosity ratio and increased lactate dehydrogenase level in patients with sickle cell anemia and recurrent leg ulcers. PLoS One. 2013 Nov 4;8(11):e79680. doi: 10.1371/journal.pone.0079680. eCollection 2013.

  PMID: 24223994 BACKGROUND

• Bunn HF, Nathan DG, Dover GJ, Hebbel RP, Platt OS, Rosse WF, Ware RE. Pulmonary hypertension and nitric oxide depletion in sickle cell disease. Blood. 2010 Aug 5;116(5):687-92. doi: 10.1182/blood-2010-02-268193. Epub 2010 Apr 15.

  PMID: 20395414 BACKGROUND

• Kato GJ, McGowan V, Machado RF, Little JA, Taylor J 6th, Morris CR, Nichols JS, Wang X, Poljakovic M, Morris SM Jr, Gladwin MT. Lactate dehydrogenase as a biomarker of hemolysis-associated nitric oxide resistance, priapism, leg ulceration, pulmonary hypertension, and death in patients with sickle cell disease. Blood. 2006 Mar 15;107(6):2279-85. doi: 10.1182/blood-2005-06-2373. Epub 2005 Nov 15.

  PMID: 16291595 BACKGROUND

• Kato GJ, Hebbel RP, Steinberg MH, Gladwin MT. Vasculopathy in sickle cell disease: Biology, pathophysiology, genetics, translational medicine, and new research directions. Am J Hematol. 2009 Sep;84(9):618-25. doi: 10.1002/ajh.21475.

  PMID: 19610078 BACKGROUND

• Nouraie M, Lee JS, Zhang Y, Kanias T, Zhao X, Xiong Z, Oriss TB, Zeng Q, Kato GJ, Gibbs JS, Hildesheim ME, Sachdev V, Barst RJ, Machado RF, Hassell KL, Little JA, Schraufnagel DE, Krishnamurti L, Novelli E, Girgis RE, Morris CR, Rosenzweig EB, Badesch DB, Lanzkron S, Castro OL, Goldsmith JC, Gordeuk VR, Gladwin MT; Walk-PHASST Investigators and Patients. The relationship between the severity of hemolysis, clinical manifestations and risk of death in 415 patients with sickle cell anemia in the US and Europe. Haematologica. 2013 Mar;98(3):464-72. doi: 10.3324/haematol.2012.068965. Epub 2012 Sep 14.

  PMID: 22983573 BACKGROUND

• Aessopos A, Farmakis D, Tsironi M, Diamanti-Kandarakis E, Matzourani M, Fragodimiri C, Hatziliami A, Karagiorga M. Endothelial function and arterial stiffness in sickle-thalassemia patients. Atherosclerosis. 2007 Apr;191(2):427-32. doi: 10.1016/j.atherosclerosis.2006.04.015. Epub 2006 May 18.

  PMID: 16712855 BACKGROUND

• Tharaux PL, Girot R, Kanfer A, Dussaule JC, Gaitz JP, Tribout L, Baudot N, Vayssairat M. Cutaneous microvascular blood flow and reactivity in patients with homozygous sickle cell anaemia. Eur J Haematol. 2002 Jun;68(6):327-31. doi: 10.1034/j.1600-0609.2002.02701.x.

  PMID: 12225389 BACKGROUND

• van Beers EJ, Schaap MC, Berckmans RJ, Nieuwland R, Sturk A, van Doormaal FF, Meijers JC, Biemond BJ; CURAMA study group. Circulating erythrocyte-derived microparticles are associated with coagulation activation in sickle cell disease. Haematologica. 2009 Nov;94(11):1513-9. doi: 10.3324/haematol.2009.008938. Epub 2009 Oct 8.

  PMID: 19815831 BACKGROUND

• Donadee C, Raat NJ, Kanias T, Tejero J, Lee JS, Kelley EE, Zhao X, Liu C, Reynolds H, Azarov I, Frizzell S, Meyer EM, Donnenberg AD, Qu L, Triulzi D, Kim-Shapiro DB, Gladwin MT. Nitric oxide scavenging by red blood cell microparticles and cell-free hemoglobin as a mechanism for the red cell storage lesion. Circulation. 2011 Jul 26;124(4):465-76. doi: 10.1161/CIRCULATIONAHA.110.008698. Epub 2011 Jul 11.

  PMID: 21747051 BACKGROUND

• Nebor D, Bowers A, Connes P, Hardy-Dessources MD, Knight-Madden J, Cumming V, Reid M, Romana M. Plasma concentration of platelet-derived microparticles is related to painful vaso-occlusive phenotype severity in sickle cell anemia. PLoS One. 2014 Jan 24;9(1):e87243. doi: 10.1371/journal.pone.0087243. eCollection 2014.

  PMID: 24475257 BACKGROUND

• Camus SM, Gausseres B, Bonnin P, Loufrani L, Grimaud L, Charue D, De Moraes JA, Renard JM, Tedgui A, Boulanger CM, Tharaux PL, Blanc-Brude OP. Erythrocyte microparticles can induce kidney vaso-occlusions in a murine model of sickle cell disease. Blood. 2012 Dec 13;120(25):5050-8. doi: 10.1182/blood-2012-02-413138. Epub 2012 Sep 13.

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• Reiter CD, Wang X, Tanus-Santos JE, Hogg N, Cannon RO 3rd, Schechter AN, Gladwin MT. Cell-free hemoglobin limits nitric oxide bioavailability in sickle-cell disease. Nat Med. 2002 Dec;8(12):1383-9. doi: 10.1038/nm1202-799. Epub 2002 Nov 11.

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Biospecimen

Retention: SAMPLES WITH DNA

3 ml of saliva for DNA extraction (sample with DNA) and 2 ml of plasma (sample with no DNA) are taken.

MeSH Terms

Conditions

Anemia, Sickle Cell; Anemia

Interventions

Biological Oxygen Demand Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Brigitte Ranque, MD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigitte Ranque, MD

CONTACT

0156092772; brigitte.ranque@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 24, 2017
• Study Start: May 15, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); MA (1)