Single-arm Multicenter Clinical Trial of Blood Transfusion From RhD+ Donors to Asian-type DEL Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 10
- 主要终点
- Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs
研究概览
简要总结
Red blood cells (RBCs) from Asian-type DEL blood group express very weak RhD antigen and are falsely typed as RhD-negative blood group in routine RhD testing. Until now, Asian-type DEL (D-eluate) patients still be treated as rare RhD-negative patients in the clinic. Previous study from the Asian-type DEL pregnant women with RhD+ fetus showed no occurrence of alloanti-D immunization. This result, however, does not directly be applied for Asian-type DEL patients receiving RhD+ blood transfusions, as lacking of direct evidence regarding the safety and underlying mechanism.
In this study, the patients with Asian-type DEL were identified and received RhD+ blood transfusion, then evaluations of any adverse reactions, especially the active follow-up alloantibody test, were prospectively conducted.
详细描述
Red blood cells (RBCs) from Asian-type DEL individuals express very weak RhD antigen and are falsely typed as RhD-negative in routine RhD testing. Recent studies have shown that 9-30% of individuals with a serologically apparent RhD-negative phenotype in East and Southeast Asian populations, including Chinese, Korean, Japanese, Thai and Myanmar, actually are not truly RhD-negative but exhibit the DEL (D-eluate) phenotype, which represents almost 1.7 million Asian-type DEL individuals in China, 250,000 in Korea, Japan, Thailand, and Myanmar as well as at least 90,000 in the US among Asian immigrants. Nowadays, Asian-type DEL patients are conventionally transfused with RhD-negative RBC, which are difficult to organize because of the undersupply of the rare RhD-negative blood in these Asian countries, due to low frequency distribution (0.3-0.4%).
However, our previous study demonstrated that Asian-type DEL pregnant women with RhD+ fetus did not develop alloanti-D during the pregnancy. Latter, this phenomenon was confirmed by different medical centers in China. Accordingly, Asian-type DEL patients may also not be able to produce alloanti-D after transfusion with RhD+ RBC and consequently the use of RhD-negative RBCs for the transfusion management of Asian-type patients may be superfluous. However, this hypothesis needs to be carefully proved.
In this study, we were able to verify this assumption. Blood samples from 2,011 Chinese patients with a primary RhD-negative phenotype from the hospitals in Guangzhou of China were typed for Asian-type DEL blood group in the Guangzhou Blood Center. DEL phenotyping was performed by the serological adsorption/elution antibody testing and genotyping for the Asian-type DEL specific allele (RHD*1227A) detection was conducted using a well validated high-resolution melting (HRM) approach. Then, transfusions of RhD+ RBC were performed in a cohort of Asian-type DEL patients. After RhD+ blood transfusion, evaluations of any adverse reactions, especially the active follow-up alloantibody test, were conducted to evaluate the alloanti-D immunization. Besides, effectiveness of transfusion (Hb changes) was also recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for eligible participants were as follows: (1) Asian-type DEL blood group; (2) male patients, or female patients ≥ 49 years of age, or female with severe illness and no plan for further pregnancy; (3) needing blood transfusion in line with guidelines for internal medicine or surgery; and (4) signed voluntary informed consent for blood transfusion treatment before the trial.
排除标准
- •were: (1) adverse reaction in a previous transfusion; (2) allergies to blood products or immunodeficiency diseases; (3) needing massive blood transfusion for acute blood loss; (4) positive pregnancy test results; (5) conscious dysfunction or severe mental illness; and (6) unsuitability for the study, as estimated by the principal investigators.
研究组 & 干预措施
Asian-type DEL recipients
First, to identify Asian-type DEL patients by phenotyping and genotyping methods in the Chinese recipients having a serologically apparent RhD-negative phenotype.
Then, blood transfusion of RhD+ blood rather than rare RhD-negative blood to the Asian-type DEL recipients which met the inclusion criteria.
干预措施: Blood transfusion (Other)
结局指标
主要结局
Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs
时间窗: A median follow-up of 226 days (range, 32 to 1354 days) after RhD+ RBC transfusion
For the Chinese Asian-type DEL recipients identified by the serological adsorption/elution test and HRM genotyping analysis, RhD+ RBC transfusion was performed. Then, the new blood samples from the patients were obtained after transfusion of RhD+ RBCs. The clinical significant alloantibodies against the common antigens of RBC were re-tested by antibody screening test. And the antibody screening test was performed using ID-DiaCell I-II-III Asia Kit (BIO-RAD, Cressier, Switzerland) in saline by the tube method and an indirect antiglobulin test (IAT) with the DG Gel Coombs card (Diagnostic Grifols, Barcelona, Spain). Meanwhile, RhCE and Asian- type DEL typing were also tested again.
次要结局
- Adverse Transfusion Reaction Analysis in Asian-type DEL Recipients During or After RhD+ Blood Transfusion(During the blood transfusion and in the days of hospitalization)