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Transfusion of D+ Blood in "Asia Type" DEL Recipients

Primary Purpose

Blood Transfusion Associated Adverse Reactions

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Blood transfusion
Sponsored by
Guangzhou Blood Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Transfusion Associated Adverse Reactions

Eligibility Criteria

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Criteria for eligible participant inclusion were: (1) all male "Asia type" DEL patients; (2) female "Asia type" DEL patients beyond the gestational age (≥49 years old); (3) female "Asia type" DEL patients within gestational age and having childbearing history but with no plan for further pregnancy due to malignant or severe disease.

Exclusion criteria were: (1) female "Asia type" DEL patients of childbearing age (commonly from 18 to 49 years old) with a need of pregnancy to prevent the potential alloanti-D immunization related hemolytic disease of fetus and newborn (HDFN); (2) female "Asia type" DEL children (<18 years old) to avoid adverse influence on the pregnancy.

Sites / Locations

  • Guangzhou Blood Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

"Asia type" DEL recipients

Arm Description

To identify "Asia type" DEL patients by phenotyping and gentoyping methods in the Chinese recipients and then blood transfusion of D+ blood rather than the rare D negative blood to the identified "Aisa type" DEL recipients.

Outcomes

Primary Outcome Measures

No occurrence of alloanti-D immunization in 33 "Asia type" DEL recipients transfused with D+ blood
For the 41 Chinese "Asia type" recipients identified by the serological adsorption/elution test and HRM genotyping analysis, the new blood samples from the patients were obtained from the 33 recipients after transfusion of D+ blood. The clinical significant alloantibodies against the common antigens of red blood cell were tested by antibody screening test. And the antibody screening test was performed using reagent cells (REAGENS, Budapest, Hungary) 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 "Asia type" DEL typing were also repeated. Then, the result showed that no alloantibody including alloanti-D was identified in all 33 recipients.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2018
Last Updated
October 9, 2019
Sponsor
Guangzhou Blood Center
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1. Study Identification

Unique Protocol Identification Number
NCT03727230
Brief Title
Transfusion of D+ Blood in "Asia Type" DEL Recipients
Official Title
Transfusion of D+ Blood to Chinese "Asia Type" DEL Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
October 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Blood Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Red blood cells (RBCs) from "Asia type" DEL blood group express very weak RhD antigen and commonly regarded as RhD negative (D-). Until now, "Asia type" DEL patients still be treated as rare D- patients in clinic. Previous study from the "Asia type" DEL pregnant women with D+ fetus showed no occurrence of alloanti-D immunization. This phenomenon, however, does not directly applicable for "Asia type" DEL patients receiving D+ blood transfusions, as different immunologic status between the pregnant women and patients may exist. In this study, to the patients identified with "Asia type" DEL phenotype and genotype, D+ blood was transfused and then alloanti-D immunization was prospectively observed.
Detailed Description
Red blood cells (RBCs) from "Asia type" DEL blood group express very weak RhD antigen and commonly regarded as RhD negative (D-). In the East and Southeast Asian populations, 9-30% D- individuals are "Asia type" DEL. Nowadays, "Asia type" DEL patients are conventionally transfused with D- RBC, which are difficult to organize based on the rarity of D- donors in our regions (0.3%). However, our previous study demonstrated that "Asia type" DEL pregnant women with D+ fetus did not develop alloanti-D during the pregnancy. Latter, this phenomenon was confirmed by different medical centers in China. Accordingly, "Asia type" DEL patients may also not be able to produce alloanti-D after transfusion with D+ RBC and consequently the use of D- RBC for the transfusion management of these patients may superfluous. However, this hypothesis needs to be carefully proved. In this study, we were able to verify this assumption. From October 2016 to October 2019, blood samples from 1264 Chinese patients with a primary D- phenotype from the hospitals in China were typed for "Asia type" DEL blood group in the Guangzhou Blood Center. DEL phenotyping was performed by the serological adsorption/elution antibody testing and genotyping for the "Asia type" DEL specific allele (RHD*1227A) using a new developed high-resolution melting (HRM) approach. Then, transfusions of D+ RBC were prepared for the cohort of "Asia type" DEL patients. After "Asia type" DEL patients received D+ blood transfusion, the follow-up antibody screening test was conducted to evaluate the alloanti-D immunization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Transfusion Associated Adverse Reactions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To identify the participators with "Asia type" DEL blood group and then transfused with D+ blood product rather than the rare D negative blood product.
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Asia type" DEL recipients
Arm Type
Other
Arm Description
To identify "Asia type" DEL patients by phenotyping and gentoyping methods in the Chinese recipients and then blood transfusion of D+ blood rather than the rare D negative blood to the identified "Aisa type" DEL recipients.
Intervention Type
Other
Intervention Name(s)
Blood transfusion
Intervention Description
Transfusion with D+ blood rather than the rare D negative blood to "Asia type" DEL recipients
Primary Outcome Measure Information:
Title
No occurrence of alloanti-D immunization in 33 "Asia type" DEL recipients transfused with D+ blood
Description
For the 41 Chinese "Asia type" recipients identified by the serological adsorption/elution test and HRM genotyping analysis, the new blood samples from the patients were obtained from the 33 recipients after transfusion of D+ blood. The clinical significant alloantibodies against the common antigens of red blood cell were tested by antibody screening test. And the antibody screening test was performed using reagent cells (REAGENS, Budapest, Hungary) 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 "Asia type" DEL typing were also repeated. Then, the result showed that no alloantibody including alloanti-D was identified in all 33 recipients.
Time Frame
Around 6 months after transfusion of D+ if possible

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Eligible participant inclusion were: (1) all male "Asia type" DEL patients; (2) female "Asia type" DEL patients beyond the gestational age (≥49 years old); (3) female "Asia type" DEL patients within gestational age and having childbearing history but with no plan for further pregnancy due to malignant or severe disease
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria for eligible participant inclusion were: (1) all male "Asia type" DEL patients; (2) female "Asia type" DEL patients beyond the gestational age (≥49 years old); (3) female "Asia type" DEL patients within gestational age and having childbearing history but with no plan for further pregnancy due to malignant or severe disease. Exclusion criteria were: (1) female "Asia type" DEL patients of childbearing age (commonly from 18 to 49 years old) with a need of pregnancy to prevent the potential alloanti-D immunization related hemolytic disease of fetus and newborn (HDFN); (2) female "Asia type" DEL children (<18 years old) to avoid adverse influence on the pregnancy.
Facility Information:
Facility Name
Guangzhou Blood Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transfusion of D+ Blood in "Asia Type" DEL Recipients

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