NCT03846089

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2005

Completed
13.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

February 16, 2019

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Graft survival

    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 Outcomes (1)

  • Patient survival

    From date of transplantation until the date of death from any cause assessed up to 300 months

Study Arms (2)

Retrograde reperfusion

After completion of the inferior vena cava anastomosis, the clamps were removed to allow retrograde reperfusion of the graft.

Procedure: Graft reperfusion

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.

Procedure: Graft reperfusion

Interventions

antegrade (forward) or retrograde (backward) blood reperfusion of the liver graft

Antegrade reperfusionRetrograde reperfusion

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • liver retransplantation
  • multiorgan transplantation
  • ABO incompatible transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Vivian McAlister

    London Health Sciences Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

February 16, 2019

First Posted

February 19, 2019

Study Start

January 1, 2002

Primary Completion

December 31, 2005

Study Completion

February 28, 2020

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
From the time of publication for 5 years
Access Criteria
By contacting the PI and with permission of the REB