Risk Factors for Allo-immunization in Sickle Cell Disease

NCT03401125 | Withdrawn

• 1 other identifier: CHUB-RETRO-ALLO
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease; Allo-immunization

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

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

Interventions

Medical file data collection OTHER

The information described in the 'outcome measures' section will be collected from the medical files of the patients.

Sickle cell disease patients (SS genotype)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Hanane EL KENZ: lead

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

Location

HUDERF

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marie Deleers, Ph Biol

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Blood Bank

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 17, 2018
• Study Start: February 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)