Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03727230
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2018-10-26
Brief Title:
RhD Blood Transfusion to Asian-type DEL Recipients
Sponsor:
Guangzhou Blood Center
Organization:
Guangzhou Blood Center
Study Overview
Official Title:
Single-arm Multicenter Clinical Trial of Blood Transfusion From RhD Donors to Asian-type DEL Recipients
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 17 million Asian-type DEL individuals in China 250000 in Korea Japan Thailand and Myanmar as well as at least 90000 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 03-04
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 2011 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 adsorptionelution antibody testing and genotyping for the Asian-type DEL specific allele RHD1227A 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
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 2011 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 adsorptionelution antibody testing and genotyping for the Asian-type DEL specific allele RHD1227A 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None