Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

January 27, 2021 updated by: Hanane EL KENZ

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)
Procedure: Blood sampling
Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis
Other: Control group
Allo-immunization not detected
Procedure: Blood sampling
Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex
Time Frame: 1 hour before blood transfusion
Sex
1 hour before blood transfusion
Chronic or acute blood transfusion
Time Frame: 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).
1 hour before blood transfusion
Blood transfusion indication
Time Frame: 1 hour before blood transfusion
Medical reason explaining the necessity of a blood transfusion
1 hour before blood transfusion
Blood donor ethnicity
Time Frame: 1 hour before blood transfusion
Blood donor ethnicity
1 hour before blood transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanane EL KENZ

Investigators

  • Principal Investigator: Marie Deleers, Ph Biol, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2018

Primary Completion (Actual)

August 3, 2020

Study Completion (Actual)

August 3, 2020

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-PRO-TRANSFU-DREPANO 1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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