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Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

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ClinicalTrials.gov Identifier: NCT03405402
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hanane EL KENZ, Brugmann University Hospital

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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Procedure: Blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


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

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




Primary Outcome Measures :
  1. Irregular antibodies [ Time Frame: 1 hour before blood transfusion ]
    Presence/abscence of irregular antibodies

  2. Irregular antibodies [ Time Frame: Between 2 to 4 weeks after blood transfusion ]
    Presence/abscence of irregular antibodies

  3. C-reactive protein (CRP) [ Time Frame: 1 hour before blood transfusion ]
    CRP dosage

  4. Cytokine [ Time Frame: 1 hour before blood transfusion ]
    Cytokine dosage

  5. Cytokine [ Time Frame: Between 2 to 4 weeks after blood transfusion ]
    Cytokine dosage

  6. Heme oxygenase [ Time Frame: 1 hour before blood transfusion ]
    Heme oxygenase dosage

  7. Heme oxygenase [ Time Frame: Between 2 to 4 weeks after blood transfusion ]
    Heme oxygenase dosage

  8. Lymphocyte typing [ Time Frame: 1 hour before blood transfusion ]
    Lymphocyte typing

  9. Lymphocyte typing [ Time Frame: Between 2 to 4 weeks after blood transfusion ]
    Lymphocyte typing


Secondary Outcome Measures :
  1. Sex [ Time Frame: 1 hour before blood transfusion ]
    Sex

  2. 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).

  3. Blood transfusion indication [ Time Frame: 1 hour before blood transfusion ]
    Medical reason explaining the necessity of a blood transfusion

  4. Blood donor ethnicity [ Time Frame: 1 hour before blood transfusion ]
    Blood donor ethnicity



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405402


Contacts
Contact: Marie Deleers, Ph Biol 32 2 477 24 09 marie.deleers@chu-brugmann.be
Contact: Hanane El Kenz, Ph Biol + 32 2 477 27 34 hanene.elkenz@chu-brugmann.be

Locations
Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Marie Deleers, Ph Biol    + 32 2 477 24 09    marie.deleers@chu-brugmann.be   
HUDERF Recruiting
Brussel, Belgium, 1020
Contact: Marie Deleers, Ph Biol    + 32 2 477 24 09    marie.deleers@chu-brugmann.be   
Sponsors and Collaborators
Hanane EL KENZ
Investigators
Principal Investigator: Marie Deleers, Ph Biol CHU Brugmann

Responsible Party: Hanane EL KENZ, Head of Blood Bank, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03405402     History of Changes
Other Study ID Numbers: CHUB-PRO-TRANSFU-DREPANO 1
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hanane EL KENZ, Brugmann University Hospital:
Sickle cell disease
Allo-immunization
Blood transfusion

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Vaccines
Immunologic Factors
Physiological Effects of Drugs