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CompletedNCT03405402Updated Jan 28, 2021

Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

An interventional study of Blood sampling in Sickle Cell Disease, sponsored by Hanane EL KENZ. Completed at 2 sites in Belgium. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Hanane EL KENZ · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
173
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Sickle Cell Disease

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Keywords

  • Sickle cell disease
  • Allo-immunization
  • Blood transfusion
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

None

04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
173 participants (actual)

Study arms

  • Experimental
    Experimental group

    Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)

    Procedure: Blood sampling

  • Other
    Control group

    Allo-immunization not detected

    Procedure: Blood sampling

Interventions

  • ProcedureBlood sampling

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

05

What researchers measure

Primary outcomes

  1. Irregular antibodies

    Presence/abscence of irregular antibodies

    Time frame: 1 hour before blood transfusion

  2. Irregular antibodies

    Presence/abscence of irregular antibodies

    Time frame: Between 2 to 4 weeks after blood transfusion

  3. C-reactive protein (CRP)

    CRP dosage

    Time frame: 1 hour before blood transfusion

  4. Cytokine

    Cytokine dosage

    Time frame: 1 hour before blood transfusion

  5. Cytokine

    Cytokine dosage

    Time frame: Between 2 to 4 weeks after blood transfusion

  6. Heme oxygenase

    Heme oxygenase dosage

    Time frame: 1 hour before blood transfusion

  7. Heme oxygenase

    Heme oxygenase dosage

    Time frame: Between 2 to 4 weeks after blood transfusion

  8. Lymphocyte typing

    Lymphocyte typing

    Time frame: 1 hour before blood transfusion

  9. Lymphocyte typing

    Lymphocyte typing

    Time frame: Between 2 to 4 weeks after blood transfusion

Secondary outcomes

  1. Sex

    Sex

    Time frame: 1 hour before blood transfusion

  2. Chronic or acute blood transfusion

    Blood transfusions planned at regular intervals of time (chronic transfusions) or performed in reaction to a medical issue (acute transfusion).

    Time frame: 1 hour before blood transfusion

  3. Blood transfusion indication

    Medical reason explaining the necessity of a blood transfusion

    Time frame: 1 hour before blood transfusion

  4. Blood donor ethnicity

    Blood donor ethnicity

    Time frame: 1 hour before blood transfusion

06

Study locations

2 sites
  • CHU Brugmann
    Brussels, 1020, Belgium
  • HUDERF
    Brussel, 1020, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03405402
Lead sponsor
Hanane EL KENZ
Responsible party
Hanane EL KENZ (Head of Blood Bank, Brugmann University Hospital) — Sponsor-investigator
First posted
Jan 23, 2018
Start date
Feb 13, 2018
Primary completion
Aug 3, 2020
Completion
Aug 3, 2020
Last update
Jan 28, 2021

Study contacts

Marie Deleers, Ph Biol
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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