Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Procedure: Blood sampling

• Registration Number: NCT03405402
• 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 and to try to understand the immunological mechanisms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-23
• Study Start: 2018-02-13
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Blood sampling	Allo-immunization not detected
Experimental group	Blood sampling	Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)

Primary Outcome Measures

Name	Time	Method
Irregular antibodies	Between 2 to 4 weeks after blood transfusion	Presence/abscence of irregular antibodies
C-reactive protein (CRP)	1 hour before blood transfusion	CRP dosage
Heme oxygenase	Between 2 to 4 weeks after blood transfusion	Heme oxygenase dosage
Cytokine	Between 2 to 4 weeks after blood transfusion	Cytokine dosage
Lymphocyte typing	Between 2 to 4 weeks after blood transfusion	Lymphocyte typing

Secondary Outcome Measures

Name	Time	Method
Chronic or acute blood transfusion	1 hour before blood transfusion	Blood transfusions planned at regular intervals of time (chronic transfusions) or performed in reaction to a medical issue (acute transfusion).
Sex	1 hour before blood transfusion	Sex
Blood donor ethnicity	1 hour before blood transfusion	Blood donor ethnicity
Blood transfusion indication	1 hour before blood transfusion	Medical reason explaining the necessity of a blood transfusion

Trial Locations

Locations (2)

CHU Brugmann; 🇧🇪 Brussels, Belgium

HUDERF; 🇧🇪 Brussel, Belgium