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

NCT03368924 | Completed DMC

• 1 other identifier: RBM-PAP-2012/47
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Despite important advances in the current understanding of sickle cell vaso-occlusion, the basis of its control and prevention remain partially unknown. The primary purpose is to test the hypothesis of a control of the sickle cell vaso-cocclusive (VOC) process by the anti band 3 antibodies by assessing the level of these antibodies in the steady state and during the crises in SCA patients. To assess the relationship between the level of band 3 antibodies, the oxidation status, the expression of microparticles and the hemorheological alterations of the sickle red cells (SS RBs), the severity of VOC.

Conditions

Sickle Cell Disease

Keywords

sickle cell anemia red blood cell oxidation; vaso-occlusive crises; anti bande 3 antibodies; red blood cell oxidation

Outcome Measures

Primary Outcomes (1)

• To compare the level of anti band 3 antibodies in steady state and during vaso-occlusive crises in SCA patients.

  Dosage of anti band 3 antibody during the steady state and the VOC

  Through study completion, an average of 3 years

Secondary Outcomes (3)

• 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

  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.

  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.

  Through study completion, an average of 3 years

Study Arms (1)

SCA patients (SS genotype)

OTHER

* To compare the level of anti band 3 antibodies in steady state and during vaso-occlusive crises in SCA patients. * 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. * 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. * 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.

Other: SCA patients (SS genotype)

Interventions

SCA patients (SS genotype) OTHER

The clinical data relative to the patients will be collected in each of these stages (CVO, basic state). Besides, to estimate the severity of the CVO, we shall use an index of severity of the episode ( IS2) adapted from the one who was validated by our group to stratify the severity of vasoocclusifs episodes at the drepanocytic child SS. Main clinical parameters: taken of analgesic at home (level), temperature in the admission, SaO2 in the admission, number of painful sites, thoracic pain with or without associated cough, score EVA in the entrance, feeling of the patient of bigger gravity of the CVO with regard to its crises previous, heart rate to the admission, … Main biological parameters: rate of leukocytes, of polynucléaires neutrophiles, of réticulocytes, Lactate déshydrogénase, of haemoglobin, C-reactive Protein … The biological data can be studied according to their raw rate or according to their difference with their basic value (in the stable state).

SCA patients (SS genotype)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Hospital University Center of Pointe-à-Pitre

Pointe-à-Pitre, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

Condition Hierarchy (Ancestors)

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

Study Officials

• Nathalie LEMONNE, Doctor specializing in SCA

  Hospital University Center of Pointe-à-Pitre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 11, 2017
• Study Start: April 9, 2013
• Primary Completion: September 19, 2015
• Study Completion: September 19, 2015
• Last Updated: December 11, 2017

Record last verified: 2017-11

Locations

GU (1)