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Trial registered on ANZCTR


Registration number
ACTRN12616001054404
Ethics application status
Approved
Date submitted
23/03/2016
Date registered
8/08/2016
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Date results information initially provided
21/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of donor white blood cell filtration to prevent donor cell survival in transfused trauma patients
Scientific title
The effectiveness of donor white blood cell filtration (leucodepletion) on the incidence of transfusion associated donor white blood cell survival (microchimerism).
Secondary ID [1] 289853 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood transfusion outcomes 298110 0
donor cell survival (microchimerism) 299793 0
Condition category
Condition code
Blood 298277 298277 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
White blood cells are thought to cause many adverse blood transfusion reactions. To remove this potential white blood cell filtration (leucodepletion) was universally introduced in Australia (became standard of care) for all red blood cell units in October 2008. Despite leucodepletion, some white blood cells still remain in each red blood cell unit. These white blood cells have been shown to survive long-term in trauma patients in studies conducted in the United States. This is a phenomenon known as microchimerism. It is still unclear what the consequences are for having these donor cells surviving and it is still unclear which patient groups are most affected. It is thought that microchimerism is more likely to establish in patients who are immunosuppressed when they receive a blood transfusion and is most likely to occur in where large volumes of blood are given. Therefore for this study trauma patients were also analysed to determine whether microchimerism occurs in Australia. These patients are immunosuppressed at the time they receive their blood transfusion and are likely to receive larger volume blood transfusions.
To determine whether this phenomenon occurs in Australia, trauma patients will be analysed in 2 groups. A retrospective (look-back) study will analyse a blood sample provided by participants who were transfused with at least one red blood cell unit before leucodepletion was universally introduced and after leucodepletion was universally introduced. Some patients in this part of the study will have received leucodepleted blood some non-leucodepleted blood depending on which year they received their blood transfusion. Filtered blood was not necessarily universal practice for each of these patients. We need to determine the incidence of microchimerism both before and after the filtration was introduced. There will be no other follow-up of these patients after the test sample is provided.
The prospective study will analyse current trauma patients who are being transfused with universally leucodepleted blood to determine whether there is a continued incidence of microchimerism, how long it takes to establish within a patient and whether they have specific biomarker changes which influence the establishment of microchimerism. Current practice is to provide leucodepleted blood to all blood transfusion recipients so all participants in this part of the study will have filtered blood. There will be a requirement for samples to be provided every 6 months for a period of 36 months following discharge from the hospital.
Intervention code [1] 294286 0
Early Detection / Screening
Comparator / control treatment
Trauma patients with no blood transfusion
Control group
Active

Outcomes
Primary outcome [1] 297763 0
Detection of long-term surviving donor white blood cell following blood transfusion assessed following quantitative real time polymerase chain reaction testing.
Timepoint [1] 297763 0
Retrospective study - up to 10 years following blood transfusion was given

Prospective study-
1)upon admission
2) 5-7 days following every blood transfusion episode
3) at discharge or every 30 days in hospital until discharge
4) every 6 months for a period of 36 months post discharge
Secondary outcome [1] 322151 0
Prospective study only -
Composite secondary outcome to analyse the immune response and cytokine profiles by cytometric bead array on plasma obtained from the blood sample and compared between patients who do or do not have microchimerism
Timepoint [1] 322151 0
1) upon admission
2) 5-7 days following every blood transfusion episode
3) at discharge or every 30 days in hospital until discharge
4) every 6 months for a period of 36 months post discharge

Eligibility
Key inclusion criteria
trauma patient ISS>12
Blood transfusion of 5 units or more in 4 hours or 10 units or more in 24 hours
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Minors under the age of 16
ISS<12
Previous blood transfusion prior to current injury
Patients with haematology condition
Mentally impaired who are not sound of mind to consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The number of participants was designed to act as a pilot study to determine if there was any potential incidence of microchimerism. With a 10% incidence found overseas, it was decided to recruit 40 participants to the study. This was a based on achievable recruitment potential since massive blood transfusions are rare. This patient number was also based on funding available to conduct the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/09/2012
Date of last participant enrolment
Anticipated
Actual
29/07/2016
Date of last data collection
Anticipated
31/07/2018
Actual
2/07/2018
Sample size
Target
89
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6410 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 6411 0
Westmead Hospital - Westmead
Recruitment hospital [3] 6412 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 6413 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 13950 0
2305 - New Lambton
Recruitment postcode(s) [2] 13951 0
2145 - Westmead
Recruitment postcode(s) [3] 13952 0
2065 - St Leonards
Recruitment postcode(s) [4] 13953 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 293193 0
Charities/Societies/Foundations
Name [1] 293193 0
Australian Red Cross Blood Service
Country [1] 293193 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Red Cross Blood Service
Address
Sydney Processing Centre
Research and Development
17 O'Riordan Street
Alexandria, Sydney, NSW 2015
Country
Australia
Secondary sponsor category [1] 291992 0
None
Name [1] 291992 0
Address [1] 291992 0
Country [1] 291992 0
Other collaborator category [1] 278915 0
Hospital
Name [1] 278915 0
John Hunter Hospital
Address [1] 278915 0
Department of traumatology
Lookout road
New Lambton Heights NSW 2305
Country [1] 278915 0
Australia
Other collaborator category [2] 278916 0
Hospital
Name [2] 278916 0
Westmead hospital
Address [2] 278916 0
Trauma Services
Hawkesbury and Darcy Road
Westmead NSW 2145
Country [2] 278916 0
Australia
Other collaborator category [3] 278917 0
Hospital
Name [3] 278917 0
Royal North Shore Hospital
Address [3] 278917 0
Department of trauma
Reserve Road
St Leonards NSW 2065
Country [3] 278917 0
Australia
Other collaborator category [4] 278918 0
Hospital
Name [4] 278918 0
Concord Hospital
Address [4] 278918 0
Burns unit
Hospital Road
Concord NSW 2139
Country [4] 278918 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294678 0
Western Sydney Local Health District
Ethics committee address [1] 294678 0
Westmead Research Office
Research & Education Network bldg
Westmead Hospital
Darcy Road
Westmead NSW 2145
Ethics committee country [1] 294678 0
Australia
Date submitted for ethics approval [1] 294678 0
01/07/2012
Approval date [1] 294678 0
30/07/2012
Ethics approval number [1] 294678 0
3533

Summary
Brief summary
The objectives of this study are to determine if leucoreduction is
effective in reducing the incidence of transfusion associated
microchimerism in major trauma patients and analyse the immune
response and cytokine profiles to determine if immunosuppressive
conditions enhance the formation of TAM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64634 0
Dr Rena Hirani
Address 64634 0
Research and Development
Australian Red Cross Blood Service
17 O'Riordan Street
Alexandria, Sydney NSW 2015

Country 64634 0
Australia
Phone 64634 0
+61 292342454
Fax 64634 0
+61 2 9234 2411
Email 64634 0
[email protected]
Contact person for public queries
Name 64635 0
Rena Hirani
Address 64635 0
Research and Development
Australian Red Cross Blood Service
17 O'Riordan Street
Alexandria, Sydney NSW 2015
Country 64635 0
Australia
Phone 64635 0
+61 292342454
Fax 64635 0
+ 61 2 9234 2411
Email 64635 0
[email protected]
Contact person for scientific queries
Name 64636 0
Rena Hirani
Address 64636 0
Research and Development
Australian Red Cross Blood Service
17 O'Riordan Street
Alexandria, Sydney NSW 2015
Country 64636 0
Australia
Phone 64636 0
+61 292342454
Fax 64636 0
+61 2 9234 2411
Email 64636 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
Individual participant data was not consented to by the participants. aggregated datasets/protocols can be provided by request


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hirani R, Dean MM, Balogh ZJ, Lott NJ, Seggie J, H... [More Details]
Study results articleYes Hirani R, Balogh ZJ, Lott NJ, Hsu JM, Irving DO. ... [More Details]

Documents added automatically
No additional documents have been identified.