HAbIT Part 1: Incidence of new Human leucocyte antigen (HLA) Antibody formation after Transfusion with blood products in patients with end stage kidney disease who are planned for live donor kidney transplant: A prospective study
- Conditions
- Anaemiakidney diseaseBlood - AnaemiaRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12618000264280
- Lead Sponsor
- Australian Red Cross Blood Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 155
5.2.1Inclusion 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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the proportion of patients with de novo blood donor-specific HLA antibodies between 6 and 8 weeks following transfusion. Antibody positivity will be defined according to standard Australian Red Cross Blood Service Transplantation and Immunogenetics Services practice, and specificity determined with reference to blood donor HLA typing. An antibody positive in the post-transfusion sample but not the pre-transfusion sample will be considered de novo for the purposes of the study. [ The timepoint for the primary outcome is visit 3, which can occur at any time between 6 and 8 weeks after the transfusion visit (visit 2).]
- Secondary Outcome Measures
Name Time Method Incidence of de novo non-DSA in participants receiving the intervention. De novo non-DSA will be defined as per de novo DSA, but where antibodies are not directed at donor epitopes. Antibody test results will be assessed by laboratory staff with expertise in HLA antibody test interpretation, who will be blinded to the status of participants.[ The timepoint for this secondary outcome is visit 3, which can occur at any time between 6 and 8 weeks after the transfusion visit (visit 2).];Compatibility assessment- median HLA compatibility of supplied product by antigen (number of antigens mismatched) and eplet score.[ Time of supply]