Risk Factors for Allo-immunization in Sickle Cell Disease

Withdrawn

• Conditions: Sickle Cell Disease
• Interventions: Other: Medical file data collection

• Registration Number: NCT03401125
• Lead Sponsor: Hanane EL KENZ

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-17
• Study Start: 2018-02-01
• Status Verified: 2018-07
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Last Update Submitted: 2018-07-25
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sickle cell disease patients (SS genotype)	Medical file data collection	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.

Primary Outcome Measures

Name	Time	Method
Date of birth	january 2013-december 2017	Date of birth
Sex	january 2013-december 2017	Sex
Blood group	january 2013-december 2017	Blood group
Extended phenotype	january 2013-december 2017	Sickle cell disease extended phenotype
Antibodies	january 2013-december 2017	Presence/absence of irregular anti-erythrocytes antibodies (RAI)
Number of blood transfusions	From birth till the first positive RAI test (up to 50 years)	Number of blood transfusions
Auto antibodies	january 2013-december 2017	Presence/absence of auto anti-erythrocytes antibodies (RAI)
Pathology	january 2013-december 2017	Medical issue causing the patient to be included in a chronic blood transfusion program
Duration of the chronic transfusion program	january 2013-december 2017	Duration of the chronic transfusion program

Trial Locations

Locations (2)

CHU Brugmann; 🇧🇪 Brussels, Belgium

HUDERF; 🇧🇪 Brussel, Belgium