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Risk Factors for Allo-immunization in Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401125
Recruitment Status : Withdrawn (Results already published by another team)
First Posted : January 17, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hanane EL KENZ, Brugmann University Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described.

The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood.

The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization in pediatric and adult patients with Sickle Cell Disease (with a SS genotype) who are being followed at Queen Fabiola University Children's Hospital (HUDERF) and at the CHU Brugmann Hospital. The identification of risk factors would allow the investigators to improve, or at least adapt, their transfusion policy to certain clinical or immuno-haematological situations.


Condition or disease Intervention/treatment
Sickle Cell Disease Other: Medical file data collection

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of the Risk Factors for Allo-immunization in Sickle Cell Disease
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Groups and Cohorts
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Group/Cohort Intervention/treatment
Sickle cell disease patients (SS genotype)
Sickle cell disease patients with a SS genotype having an history of blood transfusions within the CHU Brugmann and the Queen Fabiola Children's Hospitals.
 Other: Medical file data collection
The information described in the 'outcome measures' section will be collected from the medical files of the patients.


Outcome Measures
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Primary Outcome Measures :
  1. Date of birth [ Time Frame: january 2013-december 2017 ]
    Date of birth

  2. Sex [ Time Frame: january 2013-december 2017 ]
    Sex

  3. Blood group [ Time Frame: january 2013-december 2017 ]
    Blood group

  4. Extended phenotype [ Time Frame: january 2013-december 2017 ]
    Sickle cell disease extended phenotype

  5. Antibodies [ Time Frame: january 2013-december 2017 ]
    Presence/absence of irregular anti-erythrocytes antibodies (RAI)

  6. Number of blood transfusions [ Time Frame: january 2013-december 2017 ]
    Number of blood transfusions

  7. Number of blood transfusions [ Time Frame: From birth till the first positive RAI test (up to 50 years) ]
    Number of blood transfusions

  8. Auto antibodies [ Time Frame: january 2013-december 2017 ]
    Presence/absence of auto anti-erythrocytes antibodies (RAI)

  9. Pathology [ Time Frame: january 2013-december 2017 ]
    Medical issue causing the patient to be included in a chronic blood transfusion program

  10. Duration of the chronic transfusion program [ Time Frame: january 2013-december 2017 ]
    Duration of the chronic transfusion program


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sickle cell disease patients (HbSS genotype) with a history of blood transfusion within the CHU Brugmann and the Queen Fabiola University Hospitals.
Criteria

Inclusion Criteria:

- Sickle cell disease patients (HbSS genotype) with a history of blood transfusions within the CHU Brugmann and the Queen Fabiola University Hospitals.

Exclusion Criteria:

- None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401125


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
HUDERF
Brussel, Belgium, 1020
Sponsors and Collaborators
Hanane EL KENZ
Investigators
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Principal Investigator: Marie Deleers, Ph Biol CHU Brugmann
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hanane EL KENZ, Head of Blood Bank, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03401125    
Other Study ID Numbers: CHUB-RETRO-ALLO
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanane EL KENZ, Brugmann University Hospital:
Sickle cell disease
Allo-immunization
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn