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WithdrawnNCT03401125Updated Jul 26, 2018

Risk Factors for Allo-immunization in Sickle Cell Disease

An observational study in Sickle Cell Disease, sponsored by Hanane EL KENZ. Withdrawn at 2 sites in Belgium. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by Hanane EL KENZ · Observational

Why this study was withdrawn
Results already published by another team
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
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 in pediatric and adult patients with Sickle Cell Disease (with a SS genotype) who are being followed at Queen Fabiola University Children's Hospital (HUDERF) and at the CHU Brugmann Hospital. The identification of risk factors would allow the investigators to improve, or at least adapt, their transfusion policy to certain clinical or immuno-haematological situations.

02

Conditions studied

  • Sickle Cell Disease

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Keywords

  • Sickle cell disease
  • Allo-immunization
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Sickle cell disease patients (HbSS genotype) with a history of blood transfusion within the CHU Brugmann and the Queen Fabiola University Hospitals.

Inclusion criteria

  • Sickle cell disease patients (HbSS genotype) with a history of blood transfusions within the CHU Brugmann and the Queen Fabiola University Hospitals.

Exclusion criteria

Exclusion Criteria:

  • None
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Sickle cell disease patients (SS genotype)

    Sickle cell disease patients with a SS genotype having an history of blood transfusions within the CHU Brugmann and the Queen Fabiola Children's Hospitals.

    Other: Medical file data collection

Interventions

  • OtherMedical file data collection

    The information described in the 'outcome measures' section will be collected from the medical files of the patients.

05

What researchers measure

Primary outcomes

  1. Date of birth

    Date of birth

    Time frame: january 2013-december 2017

  2. Sex

    Sex

    Time frame: january 2013-december 2017

  3. Blood group

    Blood group

    Time frame: january 2013-december 2017

  4. Extended phenotype

    Sickle cell disease extended phenotype

    Time frame: january 2013-december 2017

  5. Antibodies

    Presence/absence of irregular anti-erythrocytes antibodies (RAI)

    Time frame: january 2013-december 2017

  6. Number of blood transfusions

    Number of blood transfusions

    Time frame: january 2013-december 2017

  7. Number of blood transfusions

    Number of blood transfusions

    Time frame: From birth till the first positive RAI test (up to 50 years)

  8. Auto antibodies

    Presence/absence of auto anti-erythrocytes antibodies (RAI)

    Time frame: january 2013-december 2017

  9. Pathology

    Medical issue causing the patient to be included in a chronic blood transfusion program

    Time frame: january 2013-december 2017

  10. Duration of the chronic transfusion program

    Duration of the chronic transfusion program

    Time frame: january 2013-december 2017

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
NCT03401125
Lead sponsor
Hanane EL KENZ
Responsible party
Hanane EL KENZ (Head of Blood Bank, Brugmann University Hospital) — Sponsor-investigator
First posted
Jan 17, 2018
Start date
Feb 1, 2018
Primary completion
Jul 1, 2018
Completion
Jul 1, 2018
Last update
Jul 26, 2018

Study contacts

Marie Deleers, Ph Biol
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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