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OpenTrials
Completed

NCT Number: NCT03405402

Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

blood sampling

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hanane EL KENZ

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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