Trial Review

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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of cadaveric donor blood in liver transplant.
Scientific title
Does use of cadaveric donor blood in orthoptic liver transplant affect blood transfusion rates
Secondary ID [1] 297341 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver transplant 311455 0
Blood transfusion 311456 0
Post operative infection 311457 0
Primary graft non function 311458 0
Condition category
Condition code
Anaesthesiology 310097 310097 0 0
Anaesthetics
Surgery 310098 310098 0 0
Other surgery
Blood 310129 310129 0 0
Other blood disorders
Infection 310130 310130 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 313590 0
Not applicable
Comparator / control treatment
Patients who underwent orthoptic liver transplant at Austin health between 2009-2018 but did not receive cadaveric donor blood.
Control group
Historical

Outcomes
Primary outcome [1] 318994 0
Use of bank blood as reported on the anesthetic chart and intraoperative fluid charts.
Timepoint [1] 318994 0
Intraoperative and ICU stay
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
Timepoint [2] 322738 0
48 hours after transplant
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.
Timepoint [3] 322739 0
7 days after transplant
Secondary outcome [1] 366675 0
Use of clotting factors as reported on the anesthetic chart and intraoperative fluid charts.
Timepoint [1] 366675 0
Intraoperative
Secondary outcome [2] 366676 0
Number of returns to theatre as documented on operation reports
Timepoint [2] 366676 0
30 days post initial transplant
Secondary outcome [3] 366679 0
Primary graft non function requiring repeat liver transplant within 30 days as documented in the hospital records
Timepoint [3] 366679 0
30 days post transplant
Secondary outcome [4] 366680 0
Post operative ICU stay taken from hospital records
Timepoint [4] 366680 0
30 days post transplant
Secondary outcome [5] 366681 0
Post operative hospital stay as documented in the hospital records
Timepoint [5] 366681 0
30 days post transplant
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
Timepoint [6] 379503 0
48 hours after transplant
Secondary outcome [7] 379504 0
New onset pulmonary infiltrates on the chest x-ray.
Timepoint [7] 379504 0
48 hours after transplant

Eligibility
Key inclusion criteria
Orthoptic liver transplant undertaken at Austin health, Victoria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/02/2019
Actual
21/02/2019
Date of last participant enrolment
Anticipated
21/02/2020
Actual
31/12/2019
Date of last data collection
Anticipated
21/02/2022
Actual
Sample size
Target
514
Accrual to date
Final
543
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13077 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 25585 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301906 0
Hospital
Name [1] 301906 0
Ruth Shaylor, Austin Health
Country [1] 301906 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Department of anaesthesia
Austin health
145 studley Road
Heidelberg
Victoria
3084
Country
Australia
Secondary sponsor category [1] 301661 0
None
Name [1] 301661 0
Address [1] 301661 0
Country [1] 301661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302594 0
Austin Health Human Resarch Ethics Committee
Ethics committee address [1] 302594 0
Ethics committee country [1] 302594 0
Australia
Date submitted for ethics approval [1] 302594 0
03/08/2018
Approval date [1] 302594 0
21/08/2018
Ethics approval number [1] 302594 0
LNR/18/Austin/353
Ethics committee name [2] 305264 0
Austin Health Human Research Ethics Comittee
Ethics committee address [2] 305264 0
Ethics committee country [2] 305264 0
Australia
Date submitted for ethics approval [2] 305264 0
14/01/2019
Approval date [2] 305264 0
17/01/2019
Ethics approval number [2] 305264 0
LNR/19/Austin/08

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

Contacts
Principal investigator
Name 90758 0
Dr Ruth Shaylor
Address 90758 0
Department of anaesthesia
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
Country 90758 0
Australia
Phone 90758 0
+61449225052
Fax 90758 0
Email 90758 0
ruth@shaylor.co.uk
Contact person for public queries
Name 90759 0
Ruth Shaylor
Address 90759 0
Department of anaesthesia
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
Country 90759 0
Australia
Phone 90759 0
+972535676112
Fax 90759 0
Email 90759 0
ruth@shaylor.co.uk
Contact person for scientific queries
Name 90760 0
Ruth Shaylor
Address 90760 0
Department of anaesthesia
Austin Health
145 Studley Road
Heidelberg
Victoria
3084
Country 90760 0
Australia
Phone 90760 0
+972 535676112
Fax 90760 0
Email 90760 0
ruth@shaylor.co.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Need to obtain approval from the liver unit at Austin health prior to any individual data publication


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6731Ethical approval  ruth@shaylor.co.uk
6732Study protocol  ruth@shaylor.co.uk
6733Statistical analysis plan  ruth@shaylor.co.uk



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.