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Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03405402
Enrollment
173
Registered
2018-01-23
Start date
2018-02-13
Completion date
2020-08-03
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease, Allo-immunization, Blood transfusion

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 and to try to understand the immunological mechanisms.

Interventions

PROCEDUREBlood sampling

Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis

Sponsors

Hanane EL KENZ
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Lymphocyte typing1 hour before blood transfusionLymphocyte typing
Irregular antibodies1 hour before blood transfusionPresence/abscence of irregular antibodies
C-reactive protein (CRP)1 hour before blood transfusionCRP dosage
Cytokine1 hour before blood transfusionCytokine dosage
Heme oxygenase1 hour before blood transfusionHeme oxygenase dosage

Secondary

MeasureTime frameDescription
Chronic or acute blood transfusion1 hour before blood transfusionBlood transfusions planned at regular intervals of time (chronic transfusions) or performed in reaction to a medical issue (acute transfusion).
Blood transfusion indication1 hour before blood transfusionMedical reason explaining the necessity of a blood transfusion
Blood donor ethnicity1 hour before blood transfusionBlood donor ethnicity
Sex1 hour before blood transfusionSex

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026