Risk Factors for Allo-immunization in Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Retrospective Study of the Risk Factors for Allo-immunization in Sickle Cell Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03401125
• Other study ID #: CHUB-RETRO-ALLO
• Status: Withdrawn
• Start date: February 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: July 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• 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.

Locations

Country	Name	City	State
Belgium	HUDERF	Brussel
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Hanane EL KENZ

Country where clinical trial is conducted

Belgium, 

Outcome

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