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

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ClinicalTrials.gov Identifier: NCT03727230
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Guangzhou Blood Center

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.


Condition or disease Intervention/treatment Phase
Blood Transfusion Associated Adverse Reactions Other: Blood transfusion Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Transfusion of D+ Blood to Chinese "Asia Type" DEL Recipients
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
"Asia type" DEL recipients
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.
Other: Blood transfusion
Transfusion with D+ blood rather than the rare D negative blood to "Asia type" DEL recipients




Primary Outcome Measures :
  1. No occurrence of alloanti-D immunization in 33 "Asia type" DEL recipients transfused with D+ blood [ Time Frame: Around 6 months after transfusion of D+ if possible ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   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
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727230


Locations
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China, Guangdong
Guangzhou Blood Center
Guangzhou, Guangdong, China, 510095
Sponsors and Collaborators
Guangzhou Blood Center

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Responsible Party: Guangzhou Blood Center
ClinicalTrials.gov Identifier: NCT03727230     History of Changes
Other Study ID Numbers: DEL
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Transfusion Reaction
Hematologic Diseases
Immune System Diseases