Retrograde Reperfusion Versus Antegrade Liver Transplant Reperfusion

April 4, 2022 updated by: Vivian McAlister, London Health Sciences Centre

A Propensity Score Matched Pair Analysis of Retrograde Reperfusion Versus Antegrade Liver Transplant Reperfusion

A retrospective cohort analysis was performed comparing patients that had intra operative antegrade liver reperfusions versus patients that had retrograde liver perfusion.

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

A retrospective cohort analysis was performed comparing patients that had intra operative antegrade liver reperfusions versus patients that had retrograde liver perfusion. Antegrade Reperfusion(ATR) group: after completing the caval replacement or piggy-back, for IVC anastomosis, Portal vein (PV) anastomosis was done with a running suture as normal fashion, then it was followed by the removal the clamps, starting by the supra hepatic VC, followed by the PV clamp and finally the infrahepatic VC. It was followed by arterial anastomosis and the biliary anastomosis (duct-to-duct if possible). Retrograde group (RETR): after completing the piggyback the IVC was declamped immediately and retrograde low pressure reperfusion of the graft with low oxygenated venous blood was established. Central venous pressure was intended to be higher than in 8 mmHg to enable appropriate retrograde reperfusion in the transplanted liver. Significant venous backflow via portal vein appears immediately after declamping. Venous bleeding from the liver except portal backflow was stopped immediately after declamping the venous anastomosis, as appropriate. Portal vein anastomosis was performed using running suture. It was followed by arterial anastomosis and the biliary anastomosis (duct-to-duct if possible). The endpoints are patient survival and graft survival at 1, 3,5, 10 years post liver transplantation in both groups. To adjust for a selection bias, we will perform a propensity score analysis.

Study Type

Observational

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who have undergone transplantation of the liver at LHSC.

Description

Inclusion Criteria:

  • all liver transplantations between 1 Jan 2002 and 31 Dec 2005

Exclusion Criteria:

  • liver retransplantation
  • multiorgan transplantation
  • ABO incompatible transplantation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrograde reperfusion
After completion of the inferior vena cava anastomosis, the clamps were removed to allow retrograde reperfusion of the graft.
antegrade (forward) or retrograde (backward) blood reperfusion of the liver graft
Antegrade reperfusion
After completion of the inferior vena cava anastomosis, the portal vein anastomosis is completed and then the clamps were removed to allow antegrade reperfusion of the graft.
antegrade (forward) or retrograde (backward) blood reperfusion of the liver graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft survival
Time Frame: From date of transplantation until the date of next transplantation or date of death from any cause, whichever came first, assessed up to 300 months
Average length of time the liver graft remains in a living recipient regardless of function
From date of transplantation until the date of next transplantation or date of death from any cause, whichever came first, assessed up to 300 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient survival
Time Frame: From date of transplantation until the date of death from any cause assessed up to 300 months
Average length of time a recipient is alive regardless of presence of the second liver
From date of transplantation until the date of death from any cause assessed up to 300 months

Collaborators and Investigators

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

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 (Actual)

January 1, 2002

Primary Completion (Actual)

December 31, 2005

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

February 16, 2019

First Submitted That Met QC Criteria

February 16, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 106793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study mechanisms and de-identified subject level data will be shared with researchers who contact the principal investigator.

IPD Sharing Time Frame

From the time of publication for 5 years

IPD Sharing Access Criteria

By contacting the PI and with permission of the REB

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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