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

Not Applicable

Completed

• Conditions: Anaemia; kidney disease; Blood - Anaemia; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12618000296235
• Lead Sponsor: Australian Red Cross Blood Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-28
• Study Completion: 2023-11-03
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: Observational
• Study Design: Not specified