Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001067460
Ethics application status
Approved
Date submitted
5/08/2016
Date registered
9/08/2016
Date last updated
8/01/2020
Date data sharing statement initially provided
21/01/2019
Date results information initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Do donor white blood cells survive in patients who need multiple blood transfusions?
Scientific title
The incidence of donor white blood cell survival (microchimerism) in transfusion dependent patients
Secondary ID [1] 289863 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood transfusion related outcomes 299806 0
microchimerism 299807 0
Condition category
Condition code
Blood 299735 299735 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a pilot observational study. Haematology patients who require chronic blood transfusion will be recruited (preferably transfusion naive when they are recruited). A research sample for testing will be collected at each time point during their current standard of care sample collections. The timepoints will be patient dependent, some patients could have weekly samples taken others every 2-3 months. The blood sample will be 3mL (1 teaspoon) in volume and will be taken prior to each blood transfusion and will be taken at the same time as other standard of care samples. This means that up to, but not limited to, 10 samples will be collected over the recruitment period of 4 years. No interventions will be applied the sample will be collected for research testing only.
Intervention code [1] 295548 0
Early Detection / Screening
Comparator / control treatment
No control group since patients will either be positive or negative for the presence of donor white blood cells after transfusion. The incidence is patient dependent and comparisons with other patient types will not be effective for this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299195 0
To determine if donor white blood cells survive in chronic blood transfusion recipients. This outcome will be tested using a sensitive genetic real time polymerase chain reaction test on specific non-coding DNA sequences.
Timepoint [1] 299195 0
Samples will be taken before transfusion (baseline)
and before each red blood cell unit is administered. These samples will be taken at the same time as other routine standard of care samples are collected (these will be patient dependent timepoints but could be up to 10 samples per patient in total)
Secondary outcome [1] 326480 0
None
Timepoint [1] 326480 0
N/A

Eligibility
Key inclusion criteria
Male and female patients 18-80 years of age.
Patients with a haematological condition who require chronic RBC transfusions.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Minors under the age of 18 and patients over the age of 80.
Mentally impaired or individuals in dependent relationships who are not sound of mind to consent to participate in this study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Directed measured outcomes. Patients will either be positive or negative for an incidence of donor white cell survival (microchimerism). The number of patients to be recruited is 200. This recruitment target is achievable in the timeframe for the student project for which this study is being conducted under. Since it is a pilot data gathering exercise, this number of patients will give a good indication on whether an incidence is present given that 10% of trauma patients in Australia were found to have microchimerism.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/09/2016
Actual
23/03/2017
Date of last participant enrolment
Anticipated
31/07/2021
Actual
30/09/2019
Date of last data collection
Anticipated
31/07/2021
Actual
23/12/2019
Sample size
Target
200
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 6423 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 6424 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 6425 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 15579 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 13965 0
5042 - Bedford Park
Recruitment postcode(s) [2] 13966 0
5000 - Adelaide
Recruitment postcode(s) [3] 13967 0
2065 - St Leonards
Recruitment postcode(s) [4] 28964 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 294241 0
Government body
Name [1] 294241 0
Australian Red Cross Blood Service
Country [1] 294241 0
Australia
Primary sponsor type
Government body
Name
Australian Red Cross Blood Service
Address
Research and Development
17 O'Riordan St
Alexandria
Sydney NSW 2015
Country
Australia
Secondary sponsor category [1] 293076 0
None
Name [1] 293076 0
Address [1] 293076 0
Country [1] 293076 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295665 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 295665 0
Research Office
Kolling Building, Level 13
Reserve Road
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 295665 0
Australia
Date submitted for ethics approval [1] 295665 0
09/05/2016
Approval date [1] 295665 0
25/07/2016
Ethics approval number [1] 295665 0
RESP/16/104

Summary
Brief summary
Chronically transfused patients receive multiple units of blood products over the course of their treatment. Multiple red blood cell (RBC) unit transfusions may lead to adverse transfusion related outcomes including the production of antibodies directed against RBC surface markers (antigens), haemolytic diseases and potential long-term donor cell survival, which is termed ‘microchimerism’.
The phenomenon of microchimerism has been documented between a mother and her fetus during pregnancy or as a result of twin-to-twin transfer in utero. However, microchimerism could also occur following organ transplantation and blood transfusion. Transfusion-associated microchimerism (TAM) is hypothesised to result from the presence of donor leucocytes present within a RBC unit. Research from the Blood Service Research & Development Team in Australia and from the Blood Systems Research Institute in the US has shown that long-term surviving donor leucocytes have been detected in up to 10% of transfused trauma patients following blood transfusion. However, it is currently unknown whether chronically transfused Australian patients could also be vulnerable to microchimerism. Therefore, chronic RBC transfusion recipients will be investigated for the incidence of microchimerism.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68042 0
Dr Rena Hirani
Address 68042 0
Research and Development
Australian Red Cross Blood Service
17 O'Riordan Street
Alexandria NSW 2015
Country 68042 0
Australia
Phone 68042 0
+61292342454
Fax 68042 0
+61292342411
Email 68042 0
[email protected]
Contact person for public queries
Name 68043 0
Dr Rena Hirani
Address 68043 0
Research and Development
Australian Red Cross Blood Service
17 O'Riordan Street
Alexandria NSW 2015
Country 68043 0
Australia
Phone 68043 0
+61292342454
Fax 68043 0
+61292342411
Email 68043 0
[email protected]
Contact person for scientific queries
Name 68044 0
Dr Rena Hirani
Address 68044 0
Research and Development
Australian Red Cross Blood Service
17 O'Riordan Street
Alexandria NSW 2015
Country 68044 0
Australia
Phone 68044 0
+61292342454
Fax 68044 0
+61292342411
Email 68044 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
participants did not consent to having individual data provided


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.