Sickle Cell AnemiaCADRENCT03114137
Heart Arteries and Sickle Cell Disease / Coeur Artères DREpanocytose
An observational study of Sickle Cell Anemia and Sickle Cell Disease, run by Cardiologie et Développement at 13 sites in 6 countries.
Trial summary
The CADRE study is a multinational observational cohort of patients with sickle-cell disease (SCD) in five west and central sub-Saharan African countries. The aim of this project is to describe the incidence and assess the predictive factors of SCD-related micro- and macro-vascular complications in sub-Saharan Africa. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Anemia, Sickle Cell Disease
- How many people
- 4,500 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Mar 2012to Dec 2022
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and adult patients with the sickle cell disease living in subSaharan Africa
Who may be able to join
- age: five-year-old or more
- signature of informed consent Patients : major sickle cell syndrome confirmed by hemoglobin phenotyping: SS, SC, SBeta+ or Sbeta0 Controls : healthy parents or siblings of the patients, hospital staff or their children, matched on age+/- 3 years and country (1 control for 4 patients)
Who cannot join
- unstable clinical status such as:
- vaso-occlusive crisis in the previous 15 days
- fever or infectious disease in the previous 15 days
- transfusion in the previous 2 months
Trial locations and contacts
13 sites in 6 countries.
Brigitte Ranque, MD PhD contact
13 sites in 6 countries
Cameroon4 sites, 4 recruiting
- Recruiting
Central Hospital of Yaounde
Yaoundé
Françoise Ngo Sacks, MD
Samuel Kingue, MD
- Recruiting
Centre mère et enfant / fondation Chantal Biya
Yaoundé
David Chelo, MD
David Chelo, MD
- Recruiting
Centre Pasteur du Cameroun
Yaoundé
Suzanne Belinga, MD
Suzanne Belinga, MD
- Recruiting
Pediatrics unit, Centre Hospitalier d'Essos
Yaoundé
guillaume Wamba, MD
Guillaume Wamba, MD
Senegal3 sites, 3 recruiting
- Recruiting
Centre hospitalier d'enfants Albert Royer
Dakar
Ibrahima Diagne, MD
Ibrahima Diagne, MD
- Recruiting
Centre hospitalo-universotaire de Fann, Cardiology department
Dakar
Bara Diop, MD
Bara Diop, MD
- Recruiting
Centre national de transfusion sanguine
Dakar
Saliou Diop, MD
Saliou Diop, MD
Côte d’Ivoire2 sites, 1 recruiting
- Recruiting
Hematology Unit, CHU Yopougon
Abidjan
Aissata Tolo, MD
Aissata Tolo, MD
- Active, not recruiting
Institut de cardiologie
Abidjan
Mali2 sites, 1 recruiting
- Active, not recruiting
Cardiology Unit, Centre gyneco-obstretrique
Bamako
- Recruiting
Centre de Recherche et de Lutte contre la Drepanocytose
Bamako
Dapa Diallo, MD
Dapa Diallo, MD
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
Centre hospitalier Monkole
Kinshasa
Leon Tshilolo, MD
Leon Tshilolo, MD
About this study
Official title: Heart, Arteries and Sikle Cell Disease, a Multicentric Cohort of Cardiovascular Complications in Subsaharan Africa
The CADRE study is a multinational observational cohort of patients with sickle-cell disease (SCD) in five west and central sub-Saharan African countries. The aim of this project is to describe the incidence and assess the predictive factors of SCD-related micro- and macro-vascular complications in sub-Saharan Africa.
Read the detailed description
Sickle cell disease (SCD), one of the lost common genetic diseases worldwide, is caused by a mutation in the β globin gene. Most patients with this disease are homozygous for the βS allele (SS), whereas others have inherited a βS allele with another mutation in the β globin gene. In addition to repeated acute ischemic insults due to the red blood cells sickling in the microcirculation, a chronic vasculopathy leads to organ injuries, such as kidney disease, stroke, pulmonary hypertension, retinopathy, bone infarcts, and leg ulcers.
CADRE is a multinational prospective observational study undertaken in five countries in sub-Saharan Africa. Patients with SCD will be recruited through outpatients' clinics in public, university and private hospitals and research centers in five countries. The CADRE protocol was approved by the relevant national ethics committee in each of the participating countries.
Primary endpoint is to measure the prevalence and the incidence of the main vascular complications in the main types of SCD: glomerulopathy, nephropathy, cardiopathy, pulmonary hypertension, retinopathy, strokes, osteonecrosis and leg ulcers.
Secondary endpoints are:
- to define the clinical and biological predictors of SCD vasculopathy in Africa
- to search for genetic risk factors for the SCD-related cardiovascular complications, in particular alpha thalassemia, persistence of foetal hemoglobin and other candidate genetic polymorphisms
- to search for functional risk factors (pulse wave velocity, capillary vasodilatation, blood visosity) for the SCD-related cardiovascular complications
- to search for new biological determinant of SCD-related cardiovascular complications, in particular alternative markers of hemolysis (microparticules, free heme) and inflammation (cytokines, leucocytes phenotyping, NET (neutrophile extracellular traps))
- Conditions
- Sickle Cell Anemia, Sickle Cell Disease
- Keywords
- Sub-Saharan Africa, Sickle Cell Disease, Vasculopathy, Nephropathy, Pulmonary hypertension, cardiac disease, hemolysis, pulse wave velocity, blood viscosity
- Medical subject headings
- Anemia, Sickle Cell, Vascular Diseases, Kidney Diseases, Hypertension, Pulmonary, Heart Diseases, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sickle cell patients | * age: five-year-old or more * major sickle cell syndrome confirmed by hemoglobin phenotype: SS, SC, SBeta+ or Sbeta0 * steady state defined as the absence of vaso-occlusive crisis for the previous 15 days, absence of fever or infectious disease for the previous 8 days and absence of transfusion for the previous 2 months | |
| control patients | * volunteer parents or siblings of sickle cell patients * hospital staff or their children matched on country and age +/- 3 ans with the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: glomerulopathy
urinary albumin/creatinin ratio (mg/g)
Measured: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: cardiopathy
left ventricular ejection fraction < 60 %
Measured: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: pulmonary hypertension
tricuspid regurgitation jet velocity (m/s)
Measured: 10 years
Prevalence and incidence and the 10 year-incidence of the main SCD-related vascular complications in different phenotypes of SCD: retinopathy
retinal examination
Measured: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:stroke
clinical diagnosis
Measured: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:osteonecrosis
standard radiography
Measured: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: leg ulcers
clinical diagnosis
Measured: 10 years
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: priapism
clinical diagnosis
Measured: 10 years
Secondary outcomes (8)
Potential biological risk marker measured at baseline and follow up visits: carotid-femoral pulse wave velocity
measured by Pulsepen, m/s)
Measured: 10 years
Potential biological risk marker measured at baseline and follow up visits: complete blood count
Measured: 10 years
Potential biological risk marker measured at baseline and follow up visits: LDH level
Measured: 10 years
Potential biological risk marker measured at baseline and follow up visits: bilirubin level
Measured: 10 years
Potential biological risk marker measured at baseline and follow up visits: microparticules measure
Measured: 10 years
Potential biological risk marker measured at baseline and follow up visits: free heme level
Measured: 10 years
Potential biological risk marker measured at baseline and follow up visits: inflammatory cytokines
Measured: 10 years
Potential biological risk marker measured at baseline and follow up visits: neutrophil extracellular traps
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startMar 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Cardiologie et Développement
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes, laboratory of excellence GR-Ex
- Responsible party
- Principal investigator, Xavier Jouven, Cardiologie et Développement
- Investigators
- Xavier Jouven, MD PhD, Principal investigator, Cardiologie et Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114137
- Sponsor's protocol ID
- 002
- Acronym
- CADRE
- Status last verified
- May 2018
- First submitted
- 30 Mar 2017
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17084951Hebbel 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.
PubMed 21264896Nouraie 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.
PubMed 22983573Gordeuk VR, Minniti CP, Nouraie M, Campbell AD, Rana SR, Luchtman-Jones L, Sable C, Dham N, Ensing G, Prchal JT, Kato GJ, Gladwin MT, Castro OL. Elevated tricuspid regurgitation velocity and decline in exercise capacity over 22 months of follow up in children and adolescents with sickle cell anemia. Haematologica. 2011 Jan;96(1):33-40. doi: 10.3324/haematol.2010.030767. Epub 2010 Sep 30.
PubMed 20884713Maier-Redelsperger M, Levy P, Lionnet F, Stankovic K, Haymann JP, Lefevre G, Avellino V, Perol JP, Girot R, Elion J. Strong association between a new marker of hemolysis and glomerulopathy in sickle cell anemia. Blood Cells Mol Dis. 2010 Dec 15;45(4):289-92. doi: 10.1016/j.bcmd.2010.08.001. Epub 2010 Sep 15.
PubMed 20833087Taylor JG 6th, Nolan VG, Mendelsohn L, Kato GJ, Gladwin MT, Steinberg MH. Chronic hyper-hemolysis in sickle cell anemia: association of vascular complications and mortality with less frequent vasoocclusive pain. PLoS One. 2008 May 7;3(5):e2095. doi: 10.1371/journal.pone.0002095.
PubMed 18461136Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients with sickle cell disease. N Engl J Med. 2004 Feb 26;350(9):886-95. doi: 10.1056/NEJMoa035477.
PubMed 14985486Kato 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.
PubMed 16291595Connes 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.
PubMed 24223994Nolan VG, Wyszynski DF, Farrer LA, Steinberg MH. Hemolysis-associated priapism in sickle cell disease. Blood. 2005 Nov 1;106(9):3264-7. doi: 10.1182/blood-2005-04-1594. Epub 2005 Jun 28.
PubMed 15985542Kato GJ, Hsieh M, Machado R, Taylor J 6th, Little J, Butman JA, Lehky T, Tisdale J, Gladwin MT. Cerebrovascular disease associated with sickle cell pulmonary hypertension. Am J Hematol. 2006 Jul;81(7):503-10. doi: 10.1002/ajh.20642.
PubMed 16755569Steinberg MH, Sebastiani P. Genetic modifiers of sickle cell disease. Am J Hematol. 2012 Aug;87(8):795-803. doi: 10.1002/ajh.23232. Epub 2012 May 28.
PubMed 22641398Ranque 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.
PubMed 27582423Ranque 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.
PubMed 27030156Ranque B, Diaw M, Dembele AK, Lapoumeroulie C, Offredo L, Tessougue O, Gueye SM, Diallo D, Diop S, Colin-Aronovicz Y, Jouven X, Blanc-Brude O, Tharaux PL, Le Jeune S, Connes P, Romana M, Le Van Kim C. Association of haemolysis markers, blood viscosity and microcirculation function with organ damage in sickle cell disease in sub-Saharan Africa (the BIOCADRE study). Br J Haematol. 2023 Oct;203(2):319-326. doi: 10.1111/bjh.19006. Epub 2023 Aug 15.
PubMed 37583261
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart, Arteries and Sikle Cell Disease, a Multicentric Cohort of Cardiovascular Complications in Subsaharan Africa
- ClinicalTrials.gov ID
- NCT03114137
- Acronym / sponsor ID
- CADRE / 002
- Conditions
- Sickle Cell Anemia, Sickle Cell Disease
- Keywords
- Sub-Saharan Africa, Sickle Cell Disease, Vasculopathy, Nephropathy, Pulmonary hypertension, cardiac disease, hemolysis, pulse wave velocity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Cardiologie et DéveloppementUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Paris 5 - Rene Descartes, laboratory of excellence GR-Ex
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CADRE study is a multinational observational cohort of patients with sickle-cell disease (SCD) in five west and central sub-Saharan African countries. The aim of this project is to describe the incidence and assess the predictive factors of SCD-related micro- and macro-vascular complications in sub-Saharan Africa.
Detailed description
Sickle cell disease (SCD), one of the lost common genetic diseases worldwide, is caused by a mutation in the β globin gene. Most patients with this disease are homozygous for the βS allele (SS), whereas others have inherited a βS allele with another mutation in the β globin gene. In addition to repeated acute ischemic insults due to the red blood cells sickling in the microcirculation, a chronic vasculopathy leads to organ injuries, such as kidney disease, stroke, pulmonary hypertension, retinopathy, bone infarcts, and leg ulcers.
CADRE is a multinational prospective observational study undertaken in five countries in sub-Saharan Africa. Patients with SCD will be recruited through outpatients' clinics in public, university and private hospitals and research centers in five countries. The CADRE protocol was approved by the relevant national ethics committee in each of the participating countries.
Primary endpoint is to measure the prevalence and the incidence of the main vascular complications in the main types of SCD: glomerulopathy, nephropathy, cardiopathy, pulmonary hypertension, retinopathy, strokes, osteonecrosis and leg ulcers.
Secondary endpoints are:
- to define the clinical and biological predictors of SCD vasculopathy in Africa
- to search for genetic risk factors for the SCD-related cardiovascular complications, in particular alpha thalassemia, persistence of foetal hemoglobin and other candidate genetic polymorphisms
- to search for functional risk factors (pulse wave velocity, capillary vasodilatation, blood visosity) for the SCD-related cardiovascular complications
- to search for new biological determinant of SCD-related cardiovascular complications, in particular alternative markers of hemolysis (microparticules, free heme) and inflammation (cytokines, leucocytes phenotyping, NET (neutrophile extracellular traps))
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sickle cell patients | – | –* age: five-year-old or more * major sickle cell syndrome confirmed by hemoglobin phenotype: SS, SC, SBeta+ or Sbeta0 * steady state defined as the absence of vaso-occlusive crisis for the previous 15 days, absence of fever or infectious disease for the previous 8 days and absence of transfusion for the previous 2 months |
| control patients | – | –* volunteer parents or siblings of sickle cell patients * hospital staff or their children matched on country and age +/- 3 ans with the patients |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adult patients with the sickle cell disease living in subSaharan Africa
Key inclusion criteria (2 listed)
- age: five-year-old or more
- signature of informed consent Patients : major sickle cell syndrome confirmed by hemoglobin phenotyping: SS, SC, SBeta+ or Sbeta0 Controls : healthy parents or siblings of the patients, hospital staff or their children, matched on age+/- 3 years and country (1 control for 4 patients)
Key exclusion criteria (4 listed)
- vaso-occlusive crisis in the previous 15 days
- fever or infectious disease in the previous 15 days
- transfusion in the previous 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: glomerulopathy
Time frame: 10 years
urinary albumin/creatinin ratio (mg/g)
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: cardiopathy
Time frame: 10 years
left ventricular ejection fraction < 60 %
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: pulmonary hypertension
Time frame: 10 years
tricuspid regurgitation jet velocity (m/s)
Prevalence and incidence and the 10 year-incidence of the main SCD-related vascular complications in different phenotypes of SCD: retinopathy
Time frame: 10 years
retinal examination
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:stroke
Time frame: 10 years
clinical diagnosis
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD:osteonecrosis
Time frame: 10 years
standard radiography
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: leg ulcers
Time frame: 10 years
clinical diagnosis
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: priapism
Time frame: 10 years
clinical diagnosis
8 secondary outcomes
Potential biological risk marker measured at baseline and follow up visits: carotid-femoral pulse wave velocity
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: complete blood count
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: LDH level
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: bilirubin level
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: microparticules measure
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: free heme level
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: inflammatory cytokines
Time frame: 10 years
Potential biological risk marker measured at baseline and follow up visits: neutrophil extracellular traps
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Background: PubMed 17084951Kato 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.
- Background: PubMed 21264896Hebbel 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.
- Background: PubMed 22983573Nouraie 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.
- Background: PubMed 20884713Gordeuk VR, Minniti CP, Nouraie M, Campbell AD, Rana SR, Luchtman-Jones L, Sable C, Dham N, Ensing G, Prchal JT, Kato GJ, Gladwin MT, Castro OL. Elevated tricuspid regurgitation velocity and decline in exercise capacity over 22 months of follow up in children and adolescents with sickle cell anemia. Haematologica. 2011 Jan;96(1):33-40. doi: 10.3324/haematol.2010.030767. Epub 2010 Sep 30.
- Background: PubMed 20833087Maier-Redelsperger M, Levy P, Lionnet F, Stankovic K, Haymann JP, Lefevre G, Avellino V, Perol JP, Girot R, Elion J. Strong association between a new marker of hemolysis and glomerulopathy in sickle cell anemia. Blood Cells Mol Dis. 2010 Dec 15;45(4):289-92. doi: 10.1016/j.bcmd.2010.08.001. Epub 2010 Sep 15.
- Background: PubMed 18461136Taylor JG 6th, Nolan VG, Mendelsohn L, Kato GJ, Gladwin MT, Steinberg MH. Chronic hyper-hemolysis in sickle cell anemia: association of vascular complications and mortality with less frequent vasoocclusive pain. PLoS One. 2008 May 7;3(5):e2095. doi: 10.1371/journal.pone.0002095.
- Background: PubMed 14985486Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients with sickle cell disease. N Engl J Med. 2004 Feb 26;350(9):886-95. doi: 10.1056/NEJMoa035477.
- Background: PubMed 16291595Kato 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.
- Background: PubMed 24223994Connes 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.
- Background: PubMed 15985542Nolan VG, Wyszynski DF, Farrer LA, Steinberg MH. Hemolysis-associated priapism in sickle cell disease. Blood. 2005 Nov 1;106(9):3264-7. doi: 10.1182/blood-2005-04-1594. Epub 2005 Jun 28.
- Background: PubMed 16755569Kato GJ, Hsieh M, Machado R, Taylor J 6th, Little J, Butman JA, Lehky T, Tisdale J, Gladwin MT. Cerebrovascular disease associated with sickle cell pulmonary hypertension. Am J Hematol. 2006 Jul;81(7):503-10. doi: 10.1002/ajh.20642.
- Background: PubMed 22641398Steinberg MH, Sebastiani P. Genetic modifiers of sickle cell disease. Am J Hematol. 2012 Aug;87(8):795-803. doi: 10.1002/ajh.23232. Epub 2012 May 28.
- Individual participant dataSharing planned: No
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Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Ranque, MD PhD contact
Xavier Jouven, MD PhD principal investigator
Cardiologie et Developpement
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Anemia and Sickle Cell Disease, run by Cardiologie et Développement at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Cameroon, Senegal, Côte d’Ivoire, Mali, Democratic Republic of the Congo and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brigitte Ranque, MD PhD (brigitte.ranque@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and 10 year-incidence of SCD-related vascular complications in different phenotypes of SCD: glomerulopathy (time frame: 10 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114137, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.