Implication of the Oxydative Stress in the Pathophysiology of Sickle Cell Anemia:

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03368924
• Date of registration: 01/12/2017
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Public title: Implication of the Oxydative Stress in the Pathophysiology of Sickle Cell Anemia: STRESS
• Scientific title: Implication of the Oxydative Stress in the Pathophysiology of Sickle Cell Anemia: Vaso-occlusive Crises, Anti Bande 3 Antibodies Levels, Red Blood Cell Oxidation
• Date of first enrolment: April 9, 2013
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03368924
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Guadeloupe

Contacts

• Name: Nathalie LEMONNE, Doctor specializing in SCA
• Affiliation: Hospital University Center of Pointe-à-Pitre

Key inclusion & exclusion criteria

Inclusion Criteria:

- adults = 18 years old SCA patients (SS genotype) hospitalized for bone VOC with single or
multifocal localizations.

Exclusion Criteria:

- chronic transfusion therapy or recent blood transfusion (less than 3 months before the
current VOC or the state defined "steady-state" in SCA);

- severe chronic renal failure; liver failure;

- autoimmune disease;

- viral hepatitis; HIV seropositivity;

- pregnancy or breast feeding;

- patients already engaged in another therapeutic clinical research protocol; -
non-compliant patients to usual care;

- patients unable to give their consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sickle Cell Disease

Intervention(s)

Other: SCA patients (SS genotype)

Primary Outcome(s)

To compare the level of anti band 3 antibodies in steady state and during vaso-occlusive crises in SCA patients. [Time Frame: Through study completion, an average of 3 years]

Secondary Outcome(s)

To assess the relationship between level of biomarkers of oxidation of SS RBCs, altered hemorheological parameters, biomarkers of cellular activation (microparticles) and anti band 3 antibodies rate, taking into account the alpha-globin genes status [Time Frame: Through study completion, an average of 3 years]

To study the relationship between level of anti band 3 antibodies and severity of these VOC using an index of clinical severity (IS2) calculated at the end of SCA patients hospitalization for VOC. [Time Frame: Through study completion, an average of 3 years]

To study early clinical (including the activity of the autonomic nervous system activity) and biological items to evaluate the relationship between these items and severity of VOC. [Time Frame: Through study completion, an average of 3 years]

Secondary ID(s)

RBM-PAP-2012/47

Source(s) of Monetary Support

Please refer to primary and secondary sponsors