Risk Factors for Allo-immunization in Sickle Cell Disease

NCT ID: NCT03401125

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Medical file data collection

Intervention Type OTHER

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

Interventions

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Medical file data collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanane EL KENZ

OTHER

Sponsor Role lead

Responsible Party

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Hanane EL KENZ

Head of Blood Bank

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marie Deleers, Ph Biol

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

HUDERF

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CHUB-RETRO-ALLO

Identifier Type: -

Identifier Source: org_study_id

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