None listed
Conditions
Brief summary
To examine a prospective cohort of patients who are planned to undergo transfusion with red blood cells (including transfusions optimised for HLA compatibility between donor and recipient), and examine the incidence of de novo formation of antibodies to blood donor HLA molecules (bDSA).
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. The number of red cell units given to correct the participant's anaemia to the satisfaction of the treating clinical team will comprise a single "transfusion event". In the absence of a satisfactory response, the "transfusion event" will end when 7 days have elapsed after the first unit was transfused.
Sponsors
Australian Red Cross Blood Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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 or has a competent parent or guardian for paediatric participants c) Transfusion must occur in a hospital setting (including satellite dialysis units) d) Anticipated to be able to provide a further blood sample 4-8 weeks post-transfusion e Patients younger than 18 years of age may be recruited from paediatric hospital sites only f) Not pregnant
Exclusion criteria
a) Blood transfusion in 4 weeks prior to enrolment or anticipated need for further transfusion in less than 4 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 4-8 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 4-8 weeks after transfusion d) Pre-existing requirement for specific red cell product (e.g. directed donation) or non red cell blood product (e.g. platelets, fresh frozen plasma)). For paediatric patients only, patients requiring plasma products in addition to the red cell transfusion may be enrolled at the discretion of the investigator. 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 relevant (in the opinion of the investigator) biologic medications targeting immune cells, that in the opinion of the investigator would affect the outcome of the trial, in 12 months prior to the trial (e.g. rituximab, bortezomib), or anticipated use of these medications in the 4 weeks post-transfusion. g) Hyperkalaemia prior to transfusion (i.e. serum potassium elevated sufficiently above the local site laboratory reference range to increase the risk associated with an irradiated transfusion, according to the investigator) or anticipated need for >4 units h) Pregnant patient i) Previous bone marrow allograft or haematological malignancy that could affect the primary outcome, in the opinion of the investigator j) Patient at risk of Transfusion-associated Graft-Versus-Host Disease (TA-GVHD) under Australian and New Zealand Society of Blood Transfusion guidelines, and/or deemed by treating clinical team to require irradiated red cells only (for adult patients only)
Outcome results
None listed