Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000419561p
Ethics application status
Submitted, not yet approved
Date submitted
20/03/2024
Date registered
5/04/2024
Date last updated
5/04/2024
Date data sharing statement initially provided
5/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of dextran in adult patient undergoing liver transplantation
Scientific title
The perioperative use of intravenous dextran in adult patient undergoing liver transplantation: a single center observational study
Secondary ID [1] 311628 0
Nil
Universal Trial Number (UTN)
U1111-1304-9265
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver transplantation 333067 0
Hepatic artery thrombosis 333068 0
Portal vein thrombosis 333069 0
Condition category
Condition code
Surgery 329752 329752 0 0
Surgical techniques
Anaesthesiology 329753 329753 0 0
Other anaesthesiology
Oral and Gastrointestinal 329754 329754 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Blood 329755 329755 0 0
Clotting disorders

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 use patient data from a single centre to investigate the association of intravenous dextran infusion with thrombotic complications such as hepatic artery thrombosis and portal vein thrombosis, in adult patients undergoing liver transplantation. In using routinely collected in-hospital data, this study will also identify independent risk factors for thrombotic complications in patients receiving dextran, as well as post-operative complications including (but not limited to) mortality, length of stay, and new co-morbidities. 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 intravenous dextran between 1st January 2014 to 29 February 2024 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 received intravenous dextran. We will seek to summarise their intraoperative course and collect data on their postoperative outcomes, including complications.
Intervention code [1] 328088 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337538 0
Hepatic artery thrombosis
Timepoint [1] 337538 0
Pre-infusion (baseline), and data for Days 1-7 post-commencement of infusion
Primary outcome [2] 337570 0
Portal vein thrombosis
Timepoint [2] 337570 0
Pre-infusion (baseline), and data for Days 1-7 post-commencement of infusion
Secondary outcome [1] 432348 0
Length of ICU Stay
Timepoint [1] 432348 0
At time of admission to ICU and time of discharge from ICU (to ward or time of death)
Secondary outcome [2] 432349 0
Length of hospital stay
Timepoint [2] 432349 0
From time of admission to time of discharge (or death, if applicable)

Eligibility
Key inclusion criteria
Inclusion Criteria:
1. Adult patient
2. Undergoing liver transplantation surgery
3. Patient receives intravenous dextran perioperatively
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Paediatric patients

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Based on a preliminary search, we expect the total sample size for the project to be approximately 300 – 350 patients.

This sample size is sufficient to meet the research aims and answer the research questions because it provides accurate data that facilitates understanding of the extent of association between IV dextran and post-operative outcomes in adult patients undergoing liver transplantation surgery.

The statistical analysis plan has been designed with a biostatistician.

All statistical analysis will be performed with R 4.3.2( R: A language and environment for statistical computing, R core Team (2023), Vienna, Austria). Continuous variables will be evaluated for normality assumption using Shapiro’s test and visual check of Q-Q plots. Data will be presented with mean ± standard deviation(SD), median (1st to 3rd quartiles) [Min:Max], or number of cases (percentile) for the descriptive statistics, and any estimated values will be described with 95% confidence intervals (CI).

Statistical results will be presented with P values and corresponding effect sizes. A 2-sided P value below 0.05 will be considered statistical significance based on the null hypothesis significance testing, and the number of effects will be evaluated with the estimated effect sizes.

For the primary objective, we use appropriate regression analysis to investigate the association of dextran use and the development of postoperative complications. The effect of IV dextran infusion on postoperative complications will be adjusted using variables that are associated with the development of postoperative thrombotic complications.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2024
Actual
Date of last participant enrolment
Anticipated
28/04/2024
Actual
Date of last data collection
Anticipated
1/05/2024
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26234 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 42202 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 315952 0
Hospital
Name [1] 315952 0
Austin Health - Department of Anaesthesia
Country [1] 315952 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Department of Anaesthesia
Address
Country
Australia
Secondary sponsor category [1] 318089 0
None
Name [1] 318089 0
Address [1] 318089 0
Country [1] 318089 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314780 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 314780 0
Ethics committee country [1] 314780 0
Australia
Date submitted for ethics approval [1] 314780 0
18/03/2024
Approval date [1] 314780 0
Ethics approval number [1] 314780 0

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

Contacts
Principal investigator
Name 132702 0
Prof Laurence Weinberg
Address 132702 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 132702 0
Australia
Phone 132702 0
+61 3 9496 3800
Fax 132702 0
Email 132702 0
[email protected]
Contact person for public queries
Name 132703 0
Laurence Weinberg
Address 132703 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 132703 0
Australia
Phone 132703 0
+61 3 9496 3800
Fax 132703 0
Email 132703 0
[email protected]
Contact person for scientific queries
Name 132704 0
Laurence Weinberg
Address 132704 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 132704 0
Australia
Phone 132704 0
+61 3 9496 3800
Fax 132704 0
Email 132704 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
Participant confidentiality will be maintained by only reporting aggregate results.


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.