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Trial registered on ANZCTR


Registration number
ACTRN12623000499684
Ethics application status
Approved
Date submitted
1/05/2023
Date registered
16/05/2023
Date last updated
11/08/2023
Date data sharing statement initially provided
16/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Veno-venous bypass adult patients undergoing liver transplantation
Scientific title
Veno-venous bypass for liver transplant adult recipients: a single center observational case series
Secondary ID [1] 309565 0
None
Universal Trial Number (UTN)
U1111-1291-9868
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver transplantation
 329860 0
Outcomes after venous venous bypass 329861 0
Condition category
Condition code
Surgery 326767 326767 0 0
Surgical techniques
Anaesthesiology 326768 326768 0 0
Other anaesthesiology
Oral and Gastrointestinal 326770 326770 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this study we will characterize the contemporary practice with the use of venous venous bypass for adult patients undergoing liver transplantation at a major Australian liver transplant center. There is no direct patient involvement, only the retrospective collection of patient data from their electronic medical records and there

Each patients' data will only be collected once and the period for which the data will be collected will from the start of their liver transplant surgery (surgical incision) to their date of hospital discharge. All patients who underwent liver transplantation and veno-venous bypass between 1st January 2010 to 1 January 2023 will have their data collected. There will be no prospective collection of any other data. Patients will not be contacted at any point.

The types of data collected will be data-linkage only. From the data collected from the electronic medical records, we will describe the baseline characteristics of those liver transplant patients who required intraoperative venous venous bypass. We will describe their intraoperative course and collect data on their postoperative outcomes, including complications. Through this case series, we aim to explore the persisting indications and practicalities of veno-venous bypass in a modern era of adult patients undergoing liver transplantation.
Intervention code [1] 325985 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334619 0
The number of adults patients undergoing liver transplantation who receive intra-operative venous venous bypass. This outcome will be obtained by reviewing data-linkage to the hospital's medical records.
Timepoint [1] 334619 0
Intra-operatively, i.e., at the time of liver transplantation during the inpatient hospital admission
Secondary outcome [1] 421428 0
The surgical indication for using venous venous bypass. This outcome will be obtained by reviewing data-linkage to the hospital's medical records.
Timepoint [1] 421428 0
Intra-operatively, i.e., at the time of liver transplantation during the inpatient hospital admission
Secondary outcome [2] 421429 0
Type of venous-venous bypass circuit used. This outcome will be obtained by reviewing data-linkage to the hospital's medical records.
Timepoint [2] 421429 0
Intra-operatively, i.e., at the time of liver transplantation during the inpatient hospital admission
Secondary outcome [3] 421431 0
Duration (in hours) for the use of venous venous bypass circuit. This outcome will be obtained by reviewing data-linkage to the hospital's medical records.
Timepoint [3] 421431 0
Intra-operatively, i.e., at the time of liver transplantation during the inpatient hospital admission
Secondary outcome [4] 421432 0
Use of blood and blood products. This outcome will be obtained by reviewing data-linkage to the hospital's medical records.
Timepoint [4] 421432 0
Intra-operatively, i.e., at the time of liver transplantation during the inpatient hospital admission
Secondary outcome [5] 421436 0
Complications following liver transplantation surgery.

Complications will be assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include graft failure, primary graft dysfunction, bile leak, infection, haemorrhage, hepatic artery or hepatic vein thrombosis, death, etc. This outcome will be obtained by reviewing data-linkage to the hospital's medical records.
Timepoint [5] 421436 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.
Secondary outcome [6] 421437 0
Specific complications of venous venous bypass. These complications will include haemothorax secondary to left subclavian artery injury, cardiac tamponade secondary to guidewire injury, air embolism, groin wound seroma, and pneumothorax.
This outcome will be obtained by reviewing data-linkage to the hospital's medical records.
Timepoint [6] 421437 0
Specific complications are considered retrospectively at discharge from the initiation of veno-venous bypass to hospital discharge for the index admission only.

Eligibility
Key inclusion criteria
Adult patients (greater or equal to 18 years) who underwent venous venous bypass during liver transplantation at Austin Health between March 2008 and March 2022.
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
Statistical analyses will be performed using GraphPad Prism software. All continuous variables will be tested for normality using the Shapiro–Wilk test. Data will be presented as counts (proportions), medians (interquartile ranges), and ranges (minimum to maximum values). Data will be de-identified and names encrypted ensuring all data are coded with numerical values. We will report this study using the The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement guidelines for reporting observational studies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2023
Actual
27/07/2023
Date of last participant enrolment
Anticipated
10/06/2023
Actual
27/07/2023
Date of last data collection
Anticipated
15/06/2023
Actual
27/07/2023
Sample size
Target
27
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24635 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 40246 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 313754 0
Hospital
Name [1] 313754 0
Austin Health
Country [1] 313754 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Department of Anaesthesia, Austin Hospital, 145 Studley Road, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 315574 0
None
Name [1] 315574 0
Address [1] 315574 0
Country [1] 315574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312925 0
Austin Health Human Research Committee
Ethics committee address [1] 312925 0
L8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
Ethics committee country [1] 312925 0
Australia
Date submitted for ethics approval [1] 312925 0
14/05/2023
Approval date [1] 312925 0
27/07/2023
Ethics approval number [1] 312925 0
HREC/100476/Austin-23

Summary
Brief summary
In an Australian context, there is a paucity of information regarding the uptake, safety and outcomes of veno-venous bypass during liver transplantation. We seek to characterise contemporary practice at a major Australian center and will conduct an observational study, describing the baseline characteristics, intra-operative course and postoperative outcomes for patients receiving VVB. Through this case series, we aim to explore the persisting indications and practicalities of veno-venous bypass in a modern era of selective use.

Who is it for?
You may be eligible for this study if you are an adult patient over 18 years of age who underwent liver transplantation at Austin Health and required veno-venous bypass as part of your standard of care.

Study details
This study will be conducted using a review of medical records, and no patient contact will be required. The study will review the medical records of adult patients who underwent liver transplantation at the above Hospital between March 2008 and March 2022.

It is hoped that this research will help to provide a better understanding of outcomes associated with venous venous bypass during surgery in this unique patient cohort.
Trial website
Trial related presentations / publications
Public notes
All adults patients undergoing liver transplantation at our institution provide written consent at the time of surgery for de-identified data to be collected and used for audit and research purposes. All patients that will be included in the retrospective observational study have provided this written consent and well as informed written surgical consent for their liver transplant procedure.

Contacts
Principal investigator
Name 126358 0
Prof Laurence Weinberg
Address 126358 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 126358 0
Australia
Phone 126358 0
+61 3 94963800
Fax 126358 0
+61 3 9459 6421
Email 126358 0
[email protected]
Contact person for public queries
Name 126359 0
Laurence Weinberg
Address 126359 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 126359 0
Australia
Phone 126359 0
+61 3 94963800
Fax 126359 0
+61 3 9459 6421
Email 126359 0
[email protected]
Contact person for scientific queries
Name 126360 0
Laurence Weinberg
Address 126360 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 126360 0
Australia
Phone 126360 0
+61 3 94963800
Fax 126360 0
+61 3 9459 6421
Email 126360 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 have not consented for their individual data to be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19985Ethical approval    385825-(Uploaded-27-07-2023-12-25-22)-Study-related document.pdf



Results publications and other study-related documents

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