A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation

NCT02423941 | Unknown DMC

• 1 other identifier: 616.36-089.843-008.6-07-037
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Liver Transplantation; Reperfusion; Delayed Graft Function

Keywords

Liver Transplantation; Retrograde Reperfusion; Graft dysfunction; Randomized study

Outcome Measures

Primary Outcomes (1)

• 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.

  1-7 postoperative days

Secondary Outcomes (3)

• Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels

  24 and 48 hours post reperfusion

• Incidence of biliary strictures (anastomotic and nonanastomotic)

  90 days after liver transplant procedure

• Incidence of in-hospital mortality

  90 days after liver transplant procedure

Study Arms (2)

Retrograde reperfusion

EXPERIMENTAL

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

Antegrade reperfusion

ACTIVE COMPARATOR

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

Interventions

Retrogade reperfusion PROCEDURE

Retrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.

Also known as: Caval reperfusion

Retrograde reperfusion

Antegrade reperfusion PROCEDURE

Antegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.

Also known as: Conventional sequential portal-arterial reperfusion

Antegrade reperfusion

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• age 18-69
• primary liver transplant
• full-size transplant
• Technique of liver transplant:
• with IVC resection;
• without veno-venous bypass;

You may not qualify if:

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

Sponsors & Collaborators

• Republican Scientific and Practical Center for Organ and Tissue Transplantation: lead

Study Sites (1)

RSPC for organ and tissue transplantation, Minsk 9th clinic

Minsk, 220116, Belarus

RECRUITING

Related Publications (3)

• 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.

  PMID: 20677285 BACKGROUND

• 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.

  PMID: 23579740 BACKGROUND

• 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.]

  BACKGROUND

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oleg O Rummo, MD PhD

  RSPC for organ and tissue transplantation, Minsk 9th clinic

  STUDY CHAIR

Central Study Contacts

Aliaksei E Shcherba, PhD

CONTACT

+375293330689; aleina@tut.by

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2015
• First Posted: April 22, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2016-12

Locations

BE (1)