Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
294074
0
None
Query!
Universal Trial Number (UTN)
U1111-1209-4464
Query!
Trial acronym
HAbIT part 2.
Query!
Linked study record
ACTRN12618000264280
Query!
Health condition
Health condition(s) or problem(s) studied:
kidney disease
306631
0
Query!
Anaemia
306630
0
Query!
Condition category
Condition code
Renal and Urogenital
305738
305738
0
0
Query!
Kidney disease
Query!
Blood
305737
305737
0
0
Query!
Anaemia
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
300346
0
Not applicable
Query!
Comparator / control treatment
No control group.
Query!
Control group
Uncontrolled
Query!
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.
Query!
Assessment method [1]
304811
0
Query!
Timepoint [1]
304811
0
6-8 weeks following the transfusion
Query!
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.
Query!
Assessment method [1]
343271
0
Query!
Timepoint [1]
343271
0
As per primary outcome, between 6 and 8 weeks post transfusion.
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose
Natural history
Query!
Duration
Longitudinal
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
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.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
7/10/2019
Query!
Actual
8/11/2019
Query!
Date of last participant enrolment
Anticipated
1/09/2023
Query!
Actual
17/07/2023
Query!
Date of last data collection
Anticipated
1/11/2023
Query!
Actual
3/11/2023
Query!
Sample size
Target
150
Query!
Accrual to date
Query!
Final
111
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
19944
0
Monash Medical Centre - Clayton campus - Clayton
Query!
Recruitment hospital [2]
19943
0
Austin Health - Austin Hospital - Heidelberg
Query!
Recruitment hospital [3]
21296
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [4]
10049
0
Royal Melbourne Hospital - City campus - Parkville
Query!
Recruitment postcode(s) [1]
34645
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [2]
34646
0
3168 - Clayton
Query!
Recruitment postcode(s) [3]
21565
0
3050 - Parkville
Query!
Recruitment postcode(s) [4]
36169
0
3128 - Box Hill
Query!
Funding & Sponsors
Funding source category [1]
298702
0
Charities/Societies/Foundations
Query!
Name [1]
298702
0
Australian Red Cross Blood Service
Query!
Address [1]
298702
0
100-154 Batman Street West Melbourne VIC 3003
Query!
Country [1]
298702
0
Australia
Query!
Primary sponsor type
Charities/Societies/Foundations
Query!
Name
Australian Red Cross Blood Service
Query!
Address
100-154 Batman Street
West Melbourne
VIC 3003
Query!
Country
Australia
Query!
Secondary sponsor category [1]
297872
0
None
Query!
Name [1]
297872
0
Query!
Address [1]
297872
0
Query!
Country [1]
297872
0
Query!
Other collaborator category [1]
279936
0
Hospital
Query!
Name [1]
279936
0
Royal Melbourne Hospital
Query!
Address [1]
279936
0
Grattan Street, Parkville VIC 3050
Query!
Country [1]
279936
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
299652
0
Australian Red Cross Blood Service HREC
Query!
Ethics committee address [1]
299652
0
17 O'Riordan Street Alexandria NSW 2015
Query!
Ethics committee country [1]
299652
0
Australia
Query!
Date submitted for ethics approval [1]
299652
0
29/01/2018
Query!
Approval date [1]
299652
0
28/05/2018
Query!
Ethics approval number [1]
299652
0
Query!
Ethics committee name [2]
303871
0
Melbourne Health Human Research Ethics Committee
Query!
Ethics committee address [2]
303871
0
Melbourne Health, Grattan Street, Parkville, VIC 3050
Query!
Ethics committee country [2]
303871
0
Australia
Query!
Date submitted for ethics approval [2]
303871
0
14/03/2018
Query!
Approval date [2]
303871
0
23/04/2018
Query!
Ethics approval number [2]
303871
0
HREC/18/MH/74
Query!
Summary
Brief summary
The aim of the project is to evaluate the risk of antibodies to blood donor proteins developing after blood transfusions, Participants will be patients who are planned to undergo a transfusion of 1 or more units of red cells. Testing for antibodies to donor proteins will be done before and 6-8 weeks after the transfusion to look for the development of new antibodies. This will help researchers to find a way to give patients blood transfusions without the risk of them developing antibodies that could put later transplants at risk.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
81178
0
Dr Jeremy McComish
Query!
Address
81178
0
Australian Red Cross Blood Service 100-154 Batman Street West Melbourne, VIC 3003
Query!
Country
81178
0
Australia
Query!
Phone
81178
0
+61 3 9694 3599
Query!
Fax
81178
0
+61 3 9694 3544
Query!
Email
81178
0
[email protected]
Query!
Contact person for public queries
Name
81179
0
Jeremy McComish
Query!
Address
81179
0
Australian Red Cross Blood Service 100-154 Batman Street West Melbourne, VIC 3003
Query!
Country
81179
0
Australia
Query!
Phone
81179
0
+61 3 9694 3599
Query!
Fax
81179
0
+61 3 9694 3544
Query!
Email
81179
0
[email protected]
Query!
Contact person for scientific queries
Name
81180
0
Jeremy McComish
Query!
Address
81180
0
Australian Red Cross Blood Service 100-154 Batman Street West Melbourne, VIC 3003
Query!
Country
81180
0
Australia
Query!
Phone
81180
0
+61 3 9694 3599
Query!
Fax
81180
0
+61 3 9694 3544
Query!
Email
81180
0
[email protected]
Query!
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.
Download to PDF