HAbIT Part 3: Human Leukocyte Antigen (HLA) antibodies after red cell transfusion- a randomised controlled trial

Not Applicable

Completed

• Conditions: anaemia; Blood - Anaemia; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12619000163101
• 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: 2019-02-05
• Study Completion: 2023-06-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified