Risk Factors for Allo-immunization in Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT03401125|
Recruitment Status : Withdrawn (Results already published by another team)
First Posted : January 17, 2018
Last Update Posted : July 26, 2018
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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 Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
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.
- Date of birth [ Time Frame: january 2013-december 2017 ]Date of birth
- Sex [ Time Frame: january 2013-december 2017 ]Sex
- Blood group [ Time Frame: january 2013-december 2017 ]Blood group
- Extended phenotype [ Time Frame: january 2013-december 2017 ]Sickle cell disease extended phenotype
- Antibodies [ Time Frame: january 2013-december 2017 ]Presence/absence of irregular anti-erythrocytes antibodies (RAI)
- Number of blood transfusions [ Time Frame: january 2013-december 2017 ]Number of blood transfusions
- Number of blood transfusions [ Time Frame: From birth till the first positive RAI test (up to 50 years) ]Number of blood transfusions
- Auto antibodies [ Time Frame: january 2013-december 2017 ]Presence/absence of auto anti-erythrocytes antibodies (RAI)
- Pathology [ Time Frame: january 2013-december 2017 ]Medical issue causing the patient to be included in a chronic blood transfusion program
- Duration of the chronic transfusion program [ Time Frame: january 2013-december 2017 ]Duration of the chronic transfusion program
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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|
- Sickle cell disease patients (HbSS genotype) with a history of blood transfusions within the CHU Brugmann and the Queen Fabiola University Hospitals.
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
|Brussels, Belgium, 1020|
|Brussel, Belgium, 1020|
|Principal Investigator:||Marie Deleers, Ph Biol||CHU Brugmann|
|Responsible Party:||Hanane EL KENZ, Head of Blood Bank, Brugmann University Hospital|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Sickle cell disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn