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Trial registered on ANZCTR
Registration number
ACTRN12619000222145
Ethics application status
Approved
Date submitted
8/02/2019
Date registered
14/02/2019
Date last updated
4/02/2020
Date data sharing statement initially provided
14/02/2019
Date results information initially provided
4/02/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Use of cadaveric donor blood in liver transplant.
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Scientific title
Does use of cadaveric donor blood in orthoptic liver transplant affect blood transfusion rates
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Secondary ID [1]
297341
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Liver transplant
311455
0
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Blood transfusion
311456
0
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Post operative infection
311457
0
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Primary graft non function
311458
0
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Condition category
Condition code
Anaesthesiology
310097
310097
0
0
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Anaesthetics
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Surgery
310098
310098
0
0
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Other surgery
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Blood
310129
310129
0
0
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Other blood disorders
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Infection
310130
310130
0
0
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Other infectious diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Patients who underwent orthoptic liver transplant at Austin health between 2009-2018 who received cadaveric donor blood. Patients records will be analysed retrospectively for 30 day outcomes. this time period referrs to 30 following the transplant. Information will be obtained from scanned and electronic hospital records
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Intervention code [1]
313590
0
Not applicable
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Comparator / control treatment
Patients who underwent orthoptic liver transplant at Austin health between 2009-2018 but did not receive cadaveric donor blood.
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Control group
Historical
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Outcomes
Primary outcome [1]
318994
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Use of bank blood as reported on the anesthetic chart and intraoperative fluid charts.
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Assessment method [1]
318994
0
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Timepoint [1]
318994
0
Intraoperative and ICU stay
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Primary outcome [2]
322738
0
Presence of transfusion related lung injury. This will require looking at intraoperative blood gas results and chest x ray reports as documented in the medical records
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Assessment method [2]
322738
0
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Timepoint [2]
322738
0
48 hours after transplant
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Primary outcome [3]
322739
0
acute deterioration in renal function. This will require looking at renal function, urine output and fluid intake as documented in the medical records.
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Assessment method [3]
322739
0
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Timepoint [3]
322739
0
7 days after transplant
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Secondary outcome [1]
366675
0
Use of clotting factors as reported on the anesthetic chart and intraoperative fluid charts.
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Assessment method [1]
366675
0
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Timepoint [1]
366675
0
Intraoperative
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Secondary outcome [2]
366676
0
Number of returns to theatre as documented on operation reports
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Assessment method [2]
366676
0
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Timepoint [2]
366676
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30 days post initial transplant
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Secondary outcome [3]
366679
0
Primary graft non function requiring repeat liver transplant within 30 days as documented in the hospital records
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Assessment method [3]
366679
0
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Timepoint [3]
366679
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30 days post transplant
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Secondary outcome [4]
366680
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Post operative ICU stay taken from hospital records
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Assessment method [4]
366680
0
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Timepoint [4]
366680
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30 days post transplant
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Secondary outcome [5]
366681
0
Post operative hospital stay as documented in the hospital records
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Assessment method [5]
366681
0
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Timepoint [5]
366681
0
30 days post transplant
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Secondary outcome [6]
379503
0
Transfusion associated cardiac overload. This will require looking at intraoperative blood gas results and chest x ray reports as documented in the medical records
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Assessment method [6]
379503
0
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Timepoint [6]
379503
0
48 hours after transplant
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Secondary outcome [7]
379504
0
New onset pulmonary infiltrates on the chest x-ray.
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Assessment method [7]
379504
0
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Timepoint [7]
379504
0
48 hours after transplant
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Eligibility
Key inclusion criteria
Orthoptic liver transplant undertaken at Austin health, Victoria
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
21/02/2019
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Actual
21/02/2019
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Date of last participant enrolment
Anticipated
21/02/2020
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Actual
31/12/2019
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Date of last data collection
Anticipated
21/02/2022
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Actual
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Sample size
Target
514
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Accrual to date
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Final
543
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
13077
0
Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
25585
0
3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
301906
0
Hospital
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Name [1]
301906
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Ruth Shaylor, Austin Health
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Address [1]
301906
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Department of anaesthesia
Austin health
145 studley Road
Heidelberg
Victoria
3084
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Country [1]
301906
0
Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
Department of anaesthesia
Austin health
145 studley Road
Heidelberg
Victoria
3084
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Country
Australia
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Secondary sponsor category [1]
301661
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None
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Name [1]
301661
0
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Address [1]
301661
0
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Country [1]
301661
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302594
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Austin Health Human Resarch Ethics Committee
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Ethics committee address [1]
302594
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Austin Health
145 STUDLEY ROAD
Heidelberg
Victoria
3084
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Ethics committee country [1]
302594
0
Australia
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Date submitted for ethics approval [1]
302594
0
03/08/2018
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Approval date [1]
302594
0
21/08/2018
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Ethics approval number [1]
302594
0
LNR/18/Austin/353
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Ethics committee name [2]
305264
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Austin Health Human Research Ethics Comittee
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Ethics committee address [2]
305264
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145 Studley Road
Heidleberg
VIC
3048
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Ethics committee country [2]
305264
0
Australia
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Date submitted for ethics approval [2]
305264
0
14/01/2019
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Approval date [2]
305264
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17/01/2019
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Ethics approval number [2]
305264
0
LNR/19/Austin/08
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Summary
Brief summary
Liver transplant (LT) can be associated with large volume blood loss and subsequent transfusion. Allogenic transfusion of bank blood (BB) has been associated with increased morbidity and mortality. In addition BB has increased cost implications. In our center cadaveric donor blood (DB) is collected in all instate recipients who are ABO and CMV compatible. Briefly DB is collected by inserting a 32Fr chest drain into the inferior vena cava and draining under suction into a cell saver reservoir prior to aortic cross clamping. Following a full cross match the DB is then processed by the cell saver and transfused into the recipient in preference to BB. A retrospective review of transfusion requirements for all patients undergoing LT was conducted to see the effects of DB on transfusion requirements in LT.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
90758
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Dr Ruth Shaylor
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Address
90758
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Department of anaesthesia
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
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Country
90758
0
Australia
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Phone
90758
0
+61449225052
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Fax
90758
0
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Email
90758
0
[email protected]
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Contact person for public queries
Name
90759
0
Dr Ruth Shaylor
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Address
90759
0
Department of anaesthesia
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
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Country
90759
0
Australia
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Phone
90759
0
+972535676112
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Fax
90759
0
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Email
90759
0
[email protected]
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Contact person for scientific queries
Name
90760
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Dr Ruth Shaylor
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Address
90760
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Department of anaesthesia
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
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Country
90760
0
Australia
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Phone
90760
0
+972 535676112
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Fax
90760
0
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Email
90760
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Need to obtain approval from the liver unit at Austin health prior to any individual data publication
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
6731
Ethical approval
[email protected]
6732
Study protocol
[email protected]
6733
Statistical analysis plan
[email protected]
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.
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