Risk Factors for Allo-immunization in Sickle Cell Disease

• ClinicalTrials.gov Identifier: NCT03401125
• Recruitment Status: Withdrawn
• First Posted: January 17, 2018
• Last Update Posted: July 26, 2018
• Sponsor: Hanane EL KENZ
• Information provided by (Responsible Party): Hanane EL KENZ, Brugmann University Hospital

Tracking Information

• First Submitted Date: January 10, 2018
• First Posted Date: January 17, 2018
• Last Update Posted Date: July 26, 2018
• Actual Study Start Date: February 1, 2018
• Actual Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 18, 2018)

• Date of birth [ Time Frame: january 2013-december 2017 ]
  Date of birth
• Sex [ Time Frame: january 2013-december 2017 ]
  Sex
• Blood group [ Time Frame: january 2013-december 2017 ]
  Blood group
• Extended phenotype [ Time Frame: january 2013-december 2017 ]
  Sickle cell disease extended phenotype
• Antibodies [ Time Frame: january 2013-december 2017 ]
  Presence/absence of irregular anti-erythrocytes antibodies (RAI)
• Number of blood transfusions [ Time Frame: january 2013-december 2017 ]
  Number of blood transfusions
• Number of blood transfusions [ Time Frame: From birth till the first positive RAI test (up to 50 years) ]
  Number of blood transfusions
• Auto antibodies [ Time Frame: january 2013-december 2017 ]
  Presence/absence of auto anti-erythrocytes antibodies (RAI)
• Pathology [ Time Frame: january 2013-december 2017 ]
  Medical issue causing the patient to be included in a chronic blood transfusion program
• Duration of the chronic transfusion program [ Time Frame: january 2013-december 2017 ]
  Duration of the chronic transfusion program

Original Primary Outcome Measures (submitted: January 10, 2018)

• Date of birth [ Time Frame: january 2013-december 2017 ]
  Date of birth
• Sex [ Time Frame: january 2013-december 2017 ]
  Sex
• Blood group [ Time Frame: january 2013-december 2017 ]
  Blood group
• Extended phenotype [ Time Frame: january 2013-december 2017 ]
  Sickle cell disease extended phenotype
• Antibodies [ Time Frame: january 2013-december 2017 ]
  Presence/absence of irregular anti-erythrocytes antibodies (RAI)
• Number of blood transfusions [ Time Frame: january 2013-december 2017 ]
  Number of blood transfusions
• Number of blood transfusions [ Time Frame: From birth till the first positive RAI test (up to 50 years) ]
  Number of blood transfusions
• Auto antibodies [ Time Frame: january 2013-december 2017 ]
  Presence/absence of auto anti-erythrocytes antibodies (RAI)
• Indications for a chronic transfusion program [ Time Frame: january 2013-december 2017 ]
  Indications for a chronic transfusion program
• Duration of the chronic transfusion program [ Time Frame: january 2013-december 2017 ]
  Duration of the chronic transfusion program

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Risk Factors for Allo-immunization in Sickle Cell Disease
• Official Title: Retrospective Study of the Risk Factors for Allo-immunization in Sickle Cell Disease

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 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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Sickle Cell Disease

Intervention

Other: Medical file data collection

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

Study Groups/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.

Intervention: Other: Medical file data collection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: July 25, 2018): 0
• Original Estimated Enrollment (submitted: January 10, 2018): 401
• Actual Study Completion Date: July 1, 2018
• Actual Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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:

- None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT03401125
• Other Study ID Numbers: CHUB-RETRO-ALLO
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hanane EL KENZ, Brugmann University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Hanane EL KENZ
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Brugmann University Hospital
• Verification Date: July 2018