Risk Factors for Allo-immunization in Sickle Cell Disease

Retrospective Study of the Risk Factors for Allo-immunization in Sickle Cell Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Other: Medical file data collection

• Study Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1020
    • Huderf
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanane EL KENZ
• Investigators: Principal Investigator: Marie Deleers, Ph Biol, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Sickle cell disease; Allo-immunization
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: CHUB-RETRO-ALLO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No