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A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation (REDLIT)

Primary Purpose

Liver Transplantation, Reperfusion, Delayed Graft Function

Status
Unknown status
Phase
Not Applicable
Locations
Belarus
Study Type
Interventional
Intervention
Retrogade reperfusion
Antegrade reperfusion
Sponsored by
Republican Scientific and Practical Center for Organ and Tissue Transplantation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplantation focused on measuring Liver Transplantation, Retrograde Reperfusion, Graft dysfunction, Randomized study

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Donor Inclusion Criteria:

  • deceased brain dead
  • age 18-59
  • length of ICU treatment up to 7 days
  • highest AST and ALT up to 200 UI/L
  • macroscopic steatosis up to 30%
  • highest serum sodium up to 165 mmol/L
  • highest bilirubin 25 µmol/L
  • application of norepinephrine is allowed
  • preservation solution - HTK (Custodiol)

Recipient inclusion Criteria:

  • age 18-69
  • primary liver transplant
  • full-size transplant

Technique of liver transplant:

  • with IVC resection;
  • without veno-venous bypass;
  • sequential portal-arterial reperfusion
  • flushing of portal vascular bed with 500 ml of called to 2-4 °C saline at back-table before implantataion

Recipient exclusion Criteria:

  • live donor liver transplant
  • reduced and split grafts;
  • multi organ failure (including fulminant and UNOS status 1);
  • fulminant hepatic failure

Sites / Locations

  • RSPC for organ and tissue transplantation, Minsk 9th clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Retrograde reperfusion

Antegrade reperfusion

Arm Description

During the transplant procedure the liver is initially reperfused retrogradely via hepatic veins. Venting of 300 ml blood is allowed via donor portal vein. After completion the portal vein anastomosis and retrograde venting of another 100 ml blood the antegrade portal reperfusion is performed.

During the transplant procedure the liver is reperfused conventionally, antegradely via portal vein after completion of caval and portal anastomoses. Venting of 300 ml blood is allowed via tube placed in infrahepatiс caval anastomosis before unclamping the vena cava.

Outcomes

Primary Outcome Measures

Incidence and severity of early graft dysfunction (EAD)
EAD will be assessed according to Olthoff KM, et al. Liver Transpl. 2010. Severe EAD will be assessed according to P.R. Salvalaggio, et al. Transplantation Proceedings, 2012.

Secondary Outcome Measures

Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Incidence of biliary strictures (anastomotic and nonanastomotic)
All biliary strictures would be diagnosed by cholangiography, either ERCP or MRCP. Ulrtrasound will be used as a screening tool to assign a cholestatic patient to cholangiography.
Incidence of in-hospital mortality

Full Information

First Posted
April 19, 2015
Last Updated
December 31, 2016
Sponsor
Republican Scientific and Practical Center for Organ and Tissue Transplantation
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1. Study Identification

Unique Protocol Identification Number
NCT02423941
Brief Title
A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation
Acronym
REDLIT
Official Title
A Randomized Clinical Study of Retrograde Caval or Antegrade Portal Reperfusion for Early Graft Dysfunction Prevention in Deceased Brain Dead Donor Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Republican Scientific and Practical Center for Organ and Tissue Transplantation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate whether retrograde caval reperfusion of liver graft could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction. All eligible enrolled liver transplant candidates will be randomized to receive either: retrograde caval, followed by sequential portal-arterial, reperfusion or antegrade, sequential portal-arterial reperfusion.
Detailed Description
We hypothesize that retrograde caval reperfusion could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction. Chi-square method of sample size estimation with a=0,05, b=0,20 and P1-P2 = 0,25 required a 41 subject per group (Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams & Wilkins, 2013). After signing the informed consent 90 patients will be randomized to study and active-control group (45 each). Only patients undergoing classical technique (retrohepatic IVC resection) of liver transplantation without vena-venous bypass will be enrolled to the study. In the study group after completion of both caval anastomoses (super and infra-hepatic) the infra-hepatic cava-clamp is released and removed allowing the filling and flushing the liver retrogradely through the hepatic veins. 300 ml of blood is drained via donor portal vein and the vein will be clamped. Suprahepatic cava-clamp is released and removed allowing venous return to the right atrium. Portal vein anastomosis will be constructed. Before the last 2-3 stitches another 100 ml will be drained retrogradely. Recipient portal vein clamp is removed and liver will be reperfused antegradely. After that arterial and biliary anastomoses will be constructed. In the control group cava-clamps are not removed until completion the portal vein anastomosis. Chi-square test and regression analysis will be used to test the difference in incidence of early allograft liver dysfunction in the study groups. Mann-Whitney test will be used to compare the median of highest aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels 24 and 48 hours post-reperfusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Reperfusion, Delayed Graft Function
Keywords
Liver Transplantation, Retrograde Reperfusion, Graft dysfunction, Randomized study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retrograde reperfusion
Arm Type
Experimental
Arm Description
During the transplant procedure the liver is initially reperfused retrogradely via hepatic veins. Venting of 300 ml blood is allowed via donor portal vein. After completion the portal vein anastomosis and retrograde venting of another 100 ml blood the antegrade portal reperfusion is performed.
Arm Title
Antegrade reperfusion
Arm Type
Active Comparator
Arm Description
During the transplant procedure the liver is reperfused conventionally, antegradely via portal vein after completion of caval and portal anastomoses. Venting of 300 ml blood is allowed via tube placed in infrahepatiс caval anastomosis before unclamping the vena cava.
Intervention Type
Procedure
Intervention Name(s)
Retrogade reperfusion
Other Intervention Name(s)
Caval reperfusion
Intervention Description
Retrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
Intervention Type
Procedure
Intervention Name(s)
Antegrade reperfusion
Other Intervention Name(s)
Conventional sequential portal-arterial reperfusion
Intervention Description
Antegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
Primary Outcome Measure Information:
Title
Incidence and severity of early graft dysfunction (EAD)
Description
EAD will be assessed according to Olthoff KM, et al. Liver Transpl. 2010. Severe EAD will be assessed according to P.R. Salvalaggio, et al. Transplantation Proceedings, 2012.
Time Frame
1-7 postoperative days
Secondary Outcome Measure Information:
Title
Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Time Frame
24 and 48 hours post reperfusion
Title
Incidence of biliary strictures (anastomotic and nonanastomotic)
Description
All biliary strictures would be diagnosed by cholangiography, either ERCP or MRCP. Ulrtrasound will be used as a screening tool to assign a cholestatic patient to cholangiography.
Time Frame
90 days after liver transplant procedure
Title
Incidence of in-hospital mortality
Time Frame
90 days after liver transplant procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Donor Inclusion Criteria: deceased brain dead age 18-59 length of ICU treatment up to 7 days highest AST and ALT up to 200 UI/L macroscopic steatosis up to 30% highest serum sodium up to 165 mmol/L highest bilirubin 25 µmol/L application of norepinephrine is allowed preservation solution - HTK (Custodiol) Recipient inclusion Criteria: age 18-69 primary liver transplant full-size transplant Technique of liver transplant: with IVC resection; without veno-venous bypass; sequential portal-arterial reperfusion flushing of portal vascular bed with 500 ml of called to 2-4 °C saline at back-table before implantataion Recipient exclusion Criteria: live donor liver transplant reduced and split grafts; multi organ failure (including fulminant and UNOS status 1); fulminant hepatic failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aliaksei E Shcherba, PhD
Phone
+375293330689
Email
aleina@tut.by
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleg O Rummo, MD PhD
Organizational Affiliation
RSPC for organ and tissue transplantation, Minsk 9th clinic
Official's Role
Study Chair
Facility Information:
Facility Name
RSPC for organ and tissue transplantation, Minsk 9th clinic
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliaksei E Shcherba, PhD
Phone
+375293330689
Email
aleina@tut.by
First Name & Middle Initial & Last Name & Degree
Denis F Efimov
Phone
+375(29)6884415
Email
den.efimoff@gmail.com
First Name & Middle Initial & Last Name & Degree
Aliaksei E Shcherba, PhD
First Name & Middle Initial & Last Name & Degree
Andrew F Minou
First Name & Middle Initial & Last Name & Degree
Evgeni O Santotski
First Name & Middle Initial & Last Name & Degree
Alexander M Dzyadzko, PhD
First Name & Middle Initial & Last Name & Degree
Denis J Efimov
First Name & Middle Initial & Last Name & Degree
Sergei V Korotkov, PhD
First Name & Middle Initial & Last Name & Degree
Oleg O Rummo, MD PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20677285
Citation
Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.
Results Reference
background
PubMed Identifier
23579740
Citation
Salvalaggio P, Afonso RC, Felga G, Ferraz-Neto BH. A proposal to grade the severity of early allograft dysfunction after liver transplantation. Einstein (Sao Paulo). 2013 Jan-Mar;11(1):23-31. doi: 10.1590/s1679-45082013000100006.
Results Reference
background
Citation
Designing Clinical Research/Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams & Wilkins, 2013.-367p.]
Results Reference
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A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation

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