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HAbIT Part 2: Incidence of new Human Leucocyte Antigen (HLA) antibody formation after transfusion with blood products in patients with and without kidney disease: A prospective study

HAbIT Part 2: Incidence of de novo Human Leucocyte Antigen (HLA) antibody formation after transfusion with blood products in patients with and without kidney disease: A prospective study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000296235
Acronym
HAbIT part 2.
Enrollment
111
Registered
2018-02-28
Start date
2019-11-08
Completion date
2023-07-17
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the project is to evaluate the risk of antibodies to blood donor proteins developing after blood transfusions, Participants will be patients who are planned to undergo a transfusion of 1 or more units of red cells. Testing for antibodies to donor proteins will be done before and 6-8 weeks after the transfusion to look for the development of new antibodies. This will help researchers to find a way to give patients blood transfusions without the risk of them developing antibodies that could put later transplants at risk.

Interventions

The exposure is a red cell transfusion, given according to Australian Patient Blood Management Guidelines. A single transfusion event will include a number of red cell units transfused on a single day. Observation will be as per local site protocol, consistent with Australian Patient Blood Management Guidelines.

Sponsors

Australian Red Cross Blood Service
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

a) Eligible for blood transfusion according to local site clinical guidelines and scheduled for a red cell transfusion on clinical grounds by participating unit b) Patient assessed as competent to consent and participate c) Transfusion must occur in a hospital setting (including satellite dialysis units) d) Anticipated to be able to provide a further blood sample 6-8 weeks post-transfusion f) > 18 years of age g) Not pregnant

Exclusion criteria

a) Blood transfusion in 6 weeks prior to enrolment, or anticipated need for further transfusion in less than 6 weeks after the study transfusion event b) Immunoglobulin therapy within 6 months prior to enrolment or scheduled within 6 weeks after enrolment (for treatments scheduled 6-8 weeks after enrolment the post-transfusion sample can be taken immediately prior to the treatment) c) Severe illness that, in the opinion of the investigator, would compromise the ability of the subject to undergo further blood tests 6-8 weeks after transfusion d) Pre-existing requirement for specific red cell product (eg directed donation) e) Urgent transfusion (such that, in the opinion of the site investigator, delay in the transfusion for enrolment and provision of the intervention product would compromise patient care) f) Use of biologic medications targeting immune cells in 12 months prior to the trial (eg rituximab, bortezomib), or anticipated use of these medications in the 6 weeks post-transfusion (for treatments scheduled 6-8 weeks after enrolment the post-transfusion sample can be taken immediately prior to the treatment) g) < 18 years of age h) Pregnant patient

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026