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

December 31, 2016 updated by: Republican Scientific and Practical Center for Organ and Tissue Transplantation

A Randomized Clinical Study of Retrograde Caval or Antegrade Portal Reperfusion for Early Graft Dysfunction Prevention in Deceased Brain Dead Donor Liver Transplantation

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:

  1. retrograde caval, followed by sequential portal-arterial, reperfusion or
  2. antegrade, sequential portal-arterial reperfusion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220116
        • Recruiting
        • RSPC for organ and tissue transplantation, Minsk 9th clinic
        • Contact:
          • Aliaksei E Shcherba, PhD
          • Phone Number: +375293330689
          • Email: aleina@tut.by
        • Contact:
        • Principal Investigator:
          • Aliaksei E Shcherba, PhD
        • Sub-Investigator:
          • Andrew F Minou
        • Sub-Investigator:
          • Evgeni O Santotski
        • Sub-Investigator:
          • Alexander M Dzyadzko, PhD
        • Sub-Investigator:
          • Denis J Efimov
        • Sub-Investigator:
          • Sergei V Korotkov, PhD
        • Sub-Investigator:
          • Oleg O Rummo, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retrograde reperfusion
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.
Procedure: Retrogade reperfusion
Retrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
Other Names:
  • Caval reperfusion
Active Comparator: Antegrade reperfusion
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.
Procedure: Antegrade reperfusion
Antegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
Other Names:
  • Conventional sequential portal-arterial reperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of early graft dysfunction (EAD)
Time Frame: 1-7 postoperative days
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.
1-7 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Time Frame: 24 and 48 hours post reperfusion
24 and 48 hours post reperfusion
Incidence of biliary strictures (anastomotic and nonanastomotic)
Time Frame: 90 days after liver transplant procedure
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.
90 days after liver transplant procedure
Incidence of in-hospital mortality
Time Frame: 90 days after liver transplant procedure
90 days after liver transplant procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Republican Scientific and Practical Center for Organ and Tissue Transplantation

Investigators

  • Study Chair: Oleg O Rummo, MD PhD, RSPC for organ and tissue transplantation, Minsk 9th clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

April 19, 2015

First Submitted That Met QC Criteria

April 19, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

December 31, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 616.36-089.843-008.6-07-037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Transplantation

Clinical Trials on Retrogade reperfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe