Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000296235
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
28/02/2018
Date last updated
28/01/2024
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
HAbIT Part 2: Incidence of de novo Human Leucocyte Antigen (HLA) antibody formation after transfusion with blood products in patients with and without kidney disease: A prospective study
Secondary ID [1] 294074 0
None
Universal Trial Number (UTN)
U1111-1209-4464
Trial acronym
HAbIT part 2.
Linked study record
ACTRN12618000264280

Health condition
Health condition(s) or problem(s) studied:
kidney disease 306631 0
Anaemia 306630 0
Condition category
Condition code
Renal and Urogenital 305738 305738 0 0
Kidney disease
Blood 305737 305737 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure is a red cell transfusion, given according to Australian Patient Blood Management Guidelines. A single transfusion event will include a number of red cell units transfused on a single day. Observation will be as per local site protocol, consistent with Australian Patient Blood Management Guidelines.
Intervention code [1] 300346 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304811 0
The primary outcome is the proportion of patients with de novo blood donor-specific HLA antibodies between 6 and 8 weeks post-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.
Timepoint [1] 304811 0
6-8 weeks following the transfusion
Secondary outcome [1] 343271 0
Incidence of de novo non-DSA in participants post transfusion. 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 the participants.
Timepoint [1] 343271 0
As per primary outcome, between 6 and 8 weeks post transfusion.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The point-estimate prevalence and 95% confidence interval for detection of de novo HLA antibodies will be calculated using standard epidemiological methods. For the Secondary endpoint analysis, both Univariate and Multivariate logistic regression will be used to analyse risk factors associated with detection of de novo HLA antibodies. Risk factors assessed include various HLA mismatch scores, pre-transfusion HLA antibodies indications, marker of inflammation pre-transfusion, and patient characteristics. Statistical models will be applied to the full cohort as well as the each subgroup. All statistical tests will be assessed as the alpha=0.05 level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/10/2019
Actual
8/11/2019
Date of last participant enrolment
Anticipated
1/09/2023
Actual
17/07/2023
Date of last data collection
Anticipated
1/11/2023
Actual
3/11/2023
Sample size
Target
150
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19944 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 19943 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 21296 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 10049 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 34645 0
3084 - Heidelberg
Recruitment postcode(s) [2] 34646 0
3168 - Clayton
Recruitment postcode(s) [3] 21565 0
3050 - Parkville
Recruitment postcode(s) [4] 36169 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 298702 0
Charities/Societies/Foundations
Name [1] 298702 0
Australian Red Cross Blood Service
Country [1] 298702 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Red Cross Blood Service
Address
100-154 Batman Street
West Melbourne
VIC 3003
Country
Australia
Secondary sponsor category [1] 297872 0
None
Name [1] 297872 0
Address [1] 297872 0
Country [1] 297872 0
Other collaborator category [1] 279936 0
Hospital
Name [1] 279936 0
Royal Melbourne Hospital
Address [1] 279936 0
Grattan Street, Parkville VIC 3050
Country [1] 279936 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299652 0
Australian Red Cross Blood Service HREC
Ethics committee address [1] 299652 0
Ethics committee country [1] 299652 0
Australia
Date submitted for ethics approval [1] 299652 0
29/01/2018
Approval date [1] 299652 0
28/05/2018
Ethics approval number [1] 299652 0
Ethics committee name [2] 303871 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [2] 303871 0
Ethics committee country [2] 303871 0
Australia
Date submitted for ethics approval [2] 303871 0
14/03/2018
Approval date [2] 303871 0
23/04/2018
Ethics approval number [2] 303871 0
HREC/18/MH/74

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81178 0
Dr Jeremy McComish
Address 81178 0
Australian Red Cross Blood Service 100-154 Batman Street West Melbourne, VIC 3003
Country 81178 0
Australia
Phone 81178 0
+61 3 9694 3599
Fax 81178 0
+61 3 9694 3544
Email 81178 0
[email protected]
Contact person for public queries
Name 81179 0
Jeremy McComish
Address 81179 0
Australian Red Cross Blood Service 100-154 Batman Street West Melbourne, VIC 3003
Country 81179 0
Australia
Phone 81179 0
+61 3 9694 3599
Fax 81179 0
+61 3 9694 3544
Email 81179 0
[email protected]
Contact person for scientific queries
Name 81180 0
Jeremy McComish
Address 81180 0
Australian Red Cross Blood Service 100-154 Batman Street West Melbourne, VIC 3003
Country 81180 0
Australia
Phone 81180 0
+61 3 9694 3599
Fax 81180 0
+61 3 9694 3544
Email 81180 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: We would aim to make deidentified IPD available where possible but need to ensure that this is consistent with relevant state and federal legislation and participant informed consent.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.