跳至主要内容
临床试验/NCT03401125
NCT03401125撤回不适用

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

Hanane EL KENZ2 个研究点 分布在 1 个国家开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Date of birth

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Date of birth

时间窗: january 2013-december 2017

Date of birth

Sex

时间窗: january 2013-december 2017

Sex

Blood group

时间窗: january 2013-december 2017

Blood group

Extended phenotype

时间窗: january 2013-december 2017

Sickle cell disease extended phenotype

Antibodies

时间窗: january 2013-december 2017

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

Number of blood transfusions

时间窗: From birth till the first positive RAI test (up to 50 years)

Number of blood transfusions

Auto antibodies

时间窗: january 2013-december 2017

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

Pathology

时间窗: january 2013-december 2017

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

Duration of the chronic transfusion program

时间窗: january 2013-december 2017

Duration of the chronic transfusion program

次要结局

未报告次要终点

研究者

发起方
Hanane EL KENZ
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hanane EL KENZ

Head of Blood Bank

Brugmann University Hospital

研究点 (2)

Loading locations...

相似试验