Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001295730
Ethics application status
Approved
Date submitted
30/10/2012
Date registered
21/11/2013
Date last updated
25/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The importance of technique of reperfusion in liver transplantation
Scientific title
The importance of the technique of reperfusion in liver transplantation: regulation of hepatic microcirculation and the pathophysiological role of endothelin-1 and stress inducible vasoactive mediators
Secondary ID [1] 281473 0
Nil
Universal Trial Number (UTN)
U1111-1136-5219
Trial acronym
MERP-TRANSPLANT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient undergoing liver Transplant 287731 0
Reperfusion technique in liver transplantation 287829 0
Condition category
Condition code
Surgery 288073 288073 0 0
Surgical techniques
Oral and Gastrointestinal 288176 288176 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients are randomised in two groups, simultaneous arterial and portal revascularization (SR group) and Initial
portal reperfusion (IPR).
In the IPR group the graft is revascularized through the portal vein, and the hepatic artery is subsequently performed. In the SR group the graft is
revascularized simultaneously through the portal vein, and hepatic artery. Both techniques are used in the clinical practice, it is based on the personal
preference of the surgeon. There is no evidence that one technique of reperfusion is superior to another or harmful. However, there is a theoretical advantage
to the simultaneous technique.
A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used 30 minutes after reperfusion.
It is hand-held probe with a sterile extension for direct contact with target tissue. The objective of the device can be sterilized with a sterile cover and drape.
Sidestream Dark Field imaging uses the absorption of hemoglobin to visualize the microcirculation using a polarized light technique, as consequence it is
completely safe. Sidestream Dark Field imaging is used at the end of reperfusion for 5 minutes
Blood sample for the serum assessment of ET-1 and other markers will be taken at indiction of anaesthesia amd post operative day 1-3-5-7.
Intervention code [1] 285976 0
Treatment: Surgery
Comparator / control treatment
The patients are randomised in two groups, simultaneous arterial and portal revascularization (SR group) and Initial
portal reperfusion (IPR) which will be deemed as the control group.
Control group
Active

Outcomes
Primary outcome [1] 288277 0
To verify the optimal technique of reperfusion in liver transplantation.
Liver functional test, endothelia-1
Timepoint [1] 288277 0
liver functional test at Post operative day-1,3,-5,7.
Secondary outcome [1] 299742 0
Mortality, prospectve data collection using custom made forms,
Timepoint [1] 299742 0
90 days
Secondary outcome [2] 300000 0
graft failure (defined as need for re-transplantation or patient death secondary to liver failure).
Timepoint [2] 300000 0
7 days

Eligibility
Key inclusion criteria
patient candidate to Liver transplant at Royal prince alfred hospital older than 18 years
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Split liver

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients are randomised in two groups, simultaneous arterial and portal revascularization (SR group) and Initial
portal reperfusion (IPR). Central randomization by computer software will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software. Patients stratified according the kind of donor used, Donor afer cardiac death versus brain dead donor
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286237 0
Hospital
Name [1] 286237 0
Australian national liver transplantation unit, Royal prince alfred hospital
Country [1] 286237 0
Australia
Primary sponsor type
Hospital
Name
Australian national liver transplantation unit Royal prince alfred hospital
Address
missenden road
Camperdown NSW, 2050
Country
Australia
Secondary sponsor category [1] 285044 0
None
Name [1] 285044 0
Address [1] 285044 0
Country [1] 285044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288317 0
Ethic review committee
Ethics committee address [1] 288317 0
Royal prince alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 288317 0
Australia
Date submitted for ethics approval [1] 288317 0
31/10/2012
Approval date [1] 288317 0
20/03/2013
Ethics approval number [1] 288317 0
hrec/12/rpah/528

Summary
Brief summary
Fifty patients undergoing liver transplant will be included in the study. The participants will be randomized in two groups using a software application. In SR group, simultaneous portal vein and hepatic artery reperfusion, while in IPR group an initial portal reperfusion and the hepatic artery reperfusion is subsequently performed. Both techniques are used in the clinical practice, it is based on the personal preference of the surgeon the type of perfusion technique used. There is no evidence that one technique of reperfusion is superior to another or harmful.Data regarding preoperative variables, intraoperative and postoperative variables are prospectively collected.
A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used.
It is hand-held probe with a sterile extension for direct contact with liver parenchyma.
Liver biopsies are performed to assess Immunohystochemical intensity of ET-1 and other markers. The tissue to be acquired in this study will be obtained from surgical specimens taken from consented participants having routine hepatic surgery or liver transplantation.
The study additionally requires the provision of a blood sample for the serum assessment of ET-1 and other markers. This blood sample will be taken at the time of clinically indicated vensection. The risks involved in drawing blood from the arm include discomfort at the site of insertion of the needle and possible bruising/swelling around the injection site. There is a very rare risk of infection. There is also a remote possibility of fainting while blood is being drawn.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34895 0
Dr Carlo Pulitano
Address 34895 0
Royal prince alfred hospital
Missenden road
transplant unit
Camperdown 2050, NSW
Country 34895 0
Australia
Phone 34895 0
0458003482
Fax 34895 0
Email 34895 0
[email protected]
Contact person for public queries
Name 18142 0
Dr Carlo Pulitano
Address 18142 0
royal prince alfred hospital
Missenden road
transplant unit
Camperdown 2050, NSW
Country 18142 0
Australia
Phone 18142 0
+61 458 003 482
Fax 18142 0
Email 18142 0
[email protected]
Contact person for scientific queries
Name 9070 0
Dr Carlo Pulitano
Address 9070 0
royal prince alfred hospital
Missenden road
transplant unit
Camperdown 2050, NSW
Country 9070 0
Australia
Phone 9070 0
+61 458 003 482
Fax 9070 0
Email 9070 0
[email protected]

No information has been provided regarding IPD availability


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.