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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03352986
Date of registration: 10/10/2017
Prospective Registration: No
Primary sponsor: Cardiologie et Développement
Public title: Substudy of CADRE: for People With Extreme Phenotype: BIOCADRE BIOCADRE
Scientific title: A Substudy of the CADRE Study: Determination of Clinical Markers in Patients With Extreme Sickle Cell Disease Phenotype
Date of first enrolment: May 15, 2017
Target sample size: 300
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03352986
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Mali Senegal
Contacts
Name:     Brigitte Ranque, MD
Address: 
Telephone: 0156092772
Email: brigitte.ranque@aphp.fr
Affiliation: 
Name:     Brigitte Ranque, MD
Address: 
Telephone:
Email:
Affiliation:  Institut National de la Santé Et de la Recherche Médicale, France
Key inclusion & exclusion criteria

Inclusion Criteria:

- sickle cell patients with extreme phenotypes: SS-hemoglobin

Exclusion Criteria:

- transfusion in the previous 2 months

- vaso-occlusive crisis in the previous 15 days

- infection in the previous 8 days



Age minimum: 10 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Sickle Cell Disease
Intervention(s)
Other: peripheral arterial tonometry
Biological: biological analysis
Primary Outcome(s)
Description of microcirculation by peripheral arterial tonometry [Time Frame: 1 year]
Secondary Outcome(s)
Measurement of neutrophil extracellular trap (NET) [Time Frame: 1 year]
Measurement of proinflammatory cytokines by ELISA [Time Frame: 1 year]
Genotyping of the polymorphisms associated with persistence of fetal hemoglobin [Time Frame: 1 year]
Dosage of microparticles [Time Frame: 1 year]
Measure of blood viscosities [Time Frame: 1 year]
Determination of free hemoglobin [Time Frame: 1 year]
Genotyping of the alpha-globin gene associated with persistence of fetal hemoglobin [Time Frame: 1 year]
Secondary ID(s)
003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Institut National de la Santé Et de la Recherche Médicale, France
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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