None listed
Conditions
Brief summary
The aim of the project is to evaluate the risk of antibodies to blood donor proteins developing after blood transfusions from blood donors selected to be compatible with the recipient. Participants will be patients who are planned to undergo a kidney transplant with a live donor. 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
HLA compatible red cell transfusion. This will be a personalised form of standard of care blood transfusion (as per Australian Patient Blood Management Guidelines), in which the blood donor will be selected to maximise HLA compatibility with the recipient. Selection will involve comparing the donor and recipient HLA types and choosing a donor who is matched as closely as possible with the recipient by HLA antigens and/or by epitope based methods. The red cells will also be irradiated, as is standard of care for red cell transfusions in some settings, but otherwise will not differ from standard of care red cell transfusion.
Sponsors
Australian Red Cross Blood Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
5.2.1 Inclusion criteria a) Eligible for blood transfusion according to local site clinical guidelines and anticipated to require 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 e) CKD patient, ESKD patient, or other patient with renal disease, potentially eligible for live donor transplant as per local site transplant unit protocol 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 4 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 (in the opinion of the investigator, delay in the transfusion for enrolment 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 4 weeks post-transfusion (for treatments scheduled 6-8 weeks after enrolment the post-transfusion sample can be taken immediately prior to the treatment)
Outcome results
None listed