A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation

NCT ID: NCT02423941

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-05-31

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

2. 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.

Conditions

Liver Transplantation; Reperfusion; Delayed Graft Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Retrogade reperfusion

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Antegrade reperfusion

Intervention Type: PROCEDURE

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

Interventions

Retrogade reperfusion

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

Intervention Type: PROCEDURE

Antegrade reperfusion

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

Intervention Type: PROCEDURE

Other Intervention Names

Caval reperfusion; Conventional sequential portal-arterial reperfusion

Eligibility Criteria

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)

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Republican Scientific and Practical Center for Organ and Tissue Transplantation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oleg O Rummo, MD PhD

Role: STUDY_CHAIR

RSPC for organ and tissue transplantation, Minsk 9th clinic

Locations

RSPC for organ and tissue transplantation, Minsk 9th clinic

Minsk, , Belarus

Site Status: RECRUITING

Countries

Belarus

Central Contacts

Aliaksei E Shcherba, PhD

Role: CONTACT

aleina@tut.by

+375293330689

Facility Contacts

Aliaksei E Shcherba, PhD

Role: primary

aleina@tut.by

+375293330689

Denis F Efimov

Role: backup

den.efimoff@gmail.com

+375(29)6884415

References

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.

Reference Type: BACKGROUND

PMID: 20677285 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23579740 (View on PubMed)

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.]

Reference Type: BACKGROUND

Other Identifiers

616.36-089.843-008.6-07-037

Identifier Type: -

Identifier Source: org_study_id