Clinical trial NCT03401125: Risk Factors for Allo-immunization in Sickle Cell Disease
Official title: Retrospective Study of the Risk Factors for Allo-immunization in Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sickle Cell Disease
Keywords: Sickle cell disease
Allo-immunization
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Date of birth
timeFrame: january 2013-december 2017
measure: Sex
timeFrame: january 2013-december 2017
measure: Blood group
timeFrame: january 2013-december 2017
measure: Extended phenotype
timeFrame: january 2013-december 2017
measure: Antibodies
timeFrame: january 2013-december 2017
measure: Number of blood transfusions
timeFrame: january 2013-december 2017
measure: Number of blood transfusions
timeFrame: From birth till the first positive RAI test (up to 50 years)
measure: Auto antibodies
timeFrame: january 2013-december 2017
measure: Pathology
timeFrame: january 2013-december 2017
measure: Duration of the chronic transfusion program
timeFrame: january 2013-december 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussel
country: Belgium
facility: HUDERF
Study officials:
affiliation: CHU Brugmann
name: Marie Deleers, Ph Biol
role: PRINCIPAL_INVESTIGATOR
References: