Blood TransfusionNCT03727230

RhD+ Blood Transfusion to Asian-type DEL Recipients

A study testing Blood transfusion in people with Blood Transfusion and Rhesus Isoimmunisation Due to Anti-D, run by Guangzhou Blood Center at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Blood Transfusion, Rhesus Isoimmunisation Due to Anti-D, Blood Group Antigen Abnormality
What is being tested?: Blood transfusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 10 sitesChina
Study dates: 1 Oct 2016to 30 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Inclusion criteria 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.

The exclusion criteria 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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Guangdong General Hospital
Guangzhou, Guangdong, 510000
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, Guangdong, 510000
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510000
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Guangzhou Blood Center
Guangzhou, Guangdong, 510095

Other trials in China

About this study

Official title: Single-arm Multicenter Clinical Trial of Blood Transfusion From RhD+ Donors to Asian-type DEL Recipients

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.

Read the 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 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.

Conditions: Blood Transfusion, Rhesus Isoimmunisation Due to Anti-D, Blood Group Antigen Abnormality
Being tested: Blood transfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood transfusionOther
Transfusion with RhD+ blood product rather than rare RhD-negative blood to Asian-type DEL recipients

Study groups in NCT03727230
Study group	Role	What they receive
Asian-type DEL recipients	Experimental	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. Receives: Other: Blood transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs
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.
Measured: A median follow-up of 226 days (range, 32 to 1354 days) after RhD+ RBC transfusion

Secondary outcomes (1)

Adverse Transfusion Reaction Analysis in Asian-type DEL Recipients During or After RhD+ Blood Transfusion
Matched D+ RBCs were provided to the 54 eligible Asian-type DEL patients by the Guangzhou Blood Center and transfused at their respective hospitals. Patients were monitored for any adverse events during transfusion and a few days thereafter, which mainly involved acute nor delayed hemolytic transfusion reactions, as well as nonhemolytic reactions, including allergic and febrile nonhemolytic reactions and circulatory overload during or after transfusion. If the symptoms of hemolysis were suspected, the laboratory biochemical measurements were also performed.
Measured: During the blood transfusion and in the days of hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201630 Nov 2021

First posted1 Nov 2018
Study start1 Oct 2016
Primary completion9 Oct 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Blood TransfusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: A single-arm clinical trial of Chinese Asian-type DEL patients receiving RhD+ RBC transfusion was conducted. Although truly RhD-negative patients receiving RhD+ RBC transfusion were recognized as the ideal control group, they were not included in this study because it did not comply with the Chinese Clinical Blood Transfusion Standard and ethics principles. The truly RhD-negative patients could receive RhD+ blood only in emergency situations under conditions of an insufficient stock of RhD-negative RBCs. Thus, the summarized alloanti-D rate (203/720, 28.2%; 95% CI, 19%-32%) in truly RhD-negative patients with similar mixed diseases after RhD+ RBC transfusion reported in the meta-analysis （Vox Sang 2021, http://doi.org/10.1111/vox.13232）was used as the control for comparison.
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03727230
Sponsor's protocol ID: DEL
Status last verified: Mar 2022
First submitted: 26 Oct 2018
Last updated: 21 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ji Y, Luo Y, Wen J, Sun Y, Jia S, Ou C, Yang W, Chen J, Ye H, Liu X, Liang Y, Lu Z, Feng Y, Wu X, Xiao M, Mo J, Zhou Z, Wang Z, Liao Z, Chen J, Wei L, Luo G, Santoso S, Fichou Y, Flegel WA, Shao C, Li C, Zhang R, Fu Y. Patients with Asian-type DEL can safely be transfused with RhD-positive blood. Blood. 2023 Apr 27;141(17):2141-2150. doi: 10.1182/blood.2022018152.
PubMed 36638337

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Blood Transfusion trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-arm Multicenter Clinical Trial of Blood Transfusion From RhD+ Donors to Asian-type DEL Recipients
ClinicalTrials.gov ID: NCT03727230
Acronym / sponsor ID: DEL
Conditions: Blood Transfusion, Rhesus Isoimmunisation Due to Anti-D, Blood Group Antigen Abnormality
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Guangzhou Blood CenterOther government
Collaborators: Sun Yat-sen University, Southern Medical University, China, Guangdong Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, Second Affiliated Hospital of Guangzhou Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Guangdong Second Provincial General Hospital, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial Institute of Biological Products And Materia Medica, Shenzhen Second People's Hospital, Koo Foundation Sun Yat-Sen Cancer Center
Study start: 1 Oct 2016 (actual)
Primary completion: 9 Oct 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 1 Nov 2018 (actual)
Results: Posted 21 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A single-arm clinical trial of Chinese Asian-type DEL patients receiving RhD+ RBC transfusion was conducted. Although truly RhD-negative patients receiving RhD+ RBC transfusion were recognized as the ideal control group, they were not included in this study because it did not comply with the Chinese Clinical Blood Transfusion Standard and ethics principles. The truly RhD-negative patients could receive RhD+ blood only in emergency situations under conditions of an insufficient stock of RhD-negative RBCs. Thus, the summarized alloanti-D rate (203/720, 28.2%; 95% CI, 19%-32%) in truly RhD-negative patients with similar mixed diseases after RhD+ RBC transfusion reported in the meta-analysis （Vox Sang 2021, http://doi.org/10.1111/vox.13232）was used as the control for comparison.

Arm	Type	Receives
Asian-type DEL recipients	Experimental	Other: Blood transfusionFirst, 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood transfusionTransfusion with RhD+ blood product rather than rare RhD-negative blood to Asian-type DEL recipients	Other	Asian-type DEL recipients

Primary outcome

Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs
Time frame: 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.

1 secondary outcome

Adverse Transfusion Reaction Analysis in Asian-type DEL Recipients During or After RhD+ Blood Transfusion
Time frame: During the blood transfusion and in the days of hospitalization

Results and safety

Results posted to the registry on 21 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Asian-type DEL Recipients	54	42

Primary outcome: Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs

Time frame: A median follow-up of 226 days (range, 32 to 1354 days) after RhD+ RBC transfusion. Count of participants. Unit: Participants

Measure	Asian-type DEL Recipients n = 54
No occurrence of alloanti-D immunization	42
Lost of follow-up	12

Asian-type DEL Recipients: p < 0.001, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Assessed up to 1354 days following transfusion, a median of 226 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Asian-type DEL Recipients	0 of 54 (0%)	0 of 54 (0%)	7 of 54

Limitations and caveats (from the sponsor): A large-scale clinical trial cannot be conducted since Asian-type DEL is rarely distributed in our population, with a frequency of approximately 0.1%. Additionally, a prudent inclusion criterion was adopted in this study to avoid potential alloanti-D immunization and negative influences on pregnancy in women of reproductive age and young girls, in which they were excluded from the trial with great caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36638337Ji Y, Luo Y, Wen J, Sun Y, Jia S, Ou C, Yang W, Chen J, Ye H, Liu X, Liang Y, Lu Z, Feng Y, Wu X, Xiao M, Mo J, Zhou Z, Wang Z, Liao Z, Chen J, Wei L, Luo G, Santoso S, Fichou Y, Flegel WA, Shao C, Li C, Zhang R, Fu Y. Patients with Asian-type DEL can safely be transfused with RhD-positive blood. Blood. 2023 Apr 27;141(17):2141-2150. doi: 10.1182/blood.2022018152.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yongshui Fu, MD, PhD study chair

Guangzhou Blood Center

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood transfusion in people with Blood Transfusion and Rhesus Isoimmunisation Due to Anti-D, run by Guangzhou Blood Center at 10 sites in China.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Alloanti-D Immunization in Asian-type DEL Recipients Transfused With RhD+ RBCs (time frame: A median follow-up of 226 days (range, 32 to 1354 days) after RhD+ RBC transfusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03727230, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.