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

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ClinicalTrials.gov Identifier: NCT02423941
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Republican Scientific and Practical Center for Organ and Tissue Transplantation

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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Reperfusion Delayed Graft Function Procedure: Retrogade reperfusion Procedure: Antegrade reperfusion Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : April 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Conventional sequential portal-arterial reperfusion




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels [ Time Frame: 24 and 48 hours post reperfusion ]
  2. 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.

  3. Incidence of in-hospital mortality [ Time Frame: 90 days after liver transplant procedure ]


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423941


Contacts
Contact: Aliaksei E Shcherba, PhD +375293330689 aleina@tut.by

Locations
Belarus
RSPC for organ and tissue transplantation, Minsk 9th clinic Recruiting
Minsk, Belarus, 220116
Contact: Aliaksei E Shcherba, PhD    +375293330689    aleina@tut.by   
Contact: Denis F Efimov    +375(29)6884415    den.efimoff@gmail.com   
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         
Sponsors and Collaborators
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:
Responsible Party: Republican Scientific and Practical Center for Organ and Tissue Transplantation
ClinicalTrials.gov Identifier: NCT02423941     History of Changes
Other Study ID Numbers: 616.36-089.843-008.6-07-037
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016

Keywords provided by Republican Scientific and Practical Center for Organ and Tissue Transplantation:
Liver Transplantation
Retrograde Reperfusion
Graft dysfunction
Randomized study

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes
Liver Extracts
Hematinics