NCT03275883

Brief Summary

The aim of this study is to determine the risk profile of hepatic artery occlusion in liver transplant recipients who received an aortohepatic conduits, analyzing all consecutive cadaveric liver transplantations from July 2007 to 31st December 2016. Medical records will be examined and adverse events will be analyzed and categorized using the Clavien-Dindo classification and Comprehensive Complication Index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
567

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

September 5, 2017

Last Update Submit

March 17, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Independent risk factors

    To identify independent risk factors for early and late occlusion of arterial conduits in liver transplantation.

    June 2007 til 31st December 2016

  • Placement sites

    To compare different placement sites (infrarenal, supraceliac, iliacal, etc.) of arterial conduits in terms of occlusion rates and graft survival

    June 2007 til 31st December 2016

  • Patency Rates

    To investigate whether antiplatelet therapy is protective in terms of arterial patency.

    June 2007 til 31st December 2016

Interventions

Placement of an interposition graft between hepatic artery and aorta during liver transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who recieved an aorto-hepatic conduit during liver transplantation

You may qualify if:

  • Liver transplantation requiring aorto-hepatic or iliac-hepatic conduits
  • Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)
  • Whole organ as well as split allografts
  • Primary liver transplantation as well as liver retransplantation
  • Recipient age ≥18 years

You may not qualify if:

  • Living donor liver transplantation
  • Pediatric liver transplantation (recipient age \<18 years)
  • Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits
  • Multivisceral transplantations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 8, 2017

Study Start

September 1, 2017

Primary Completion

September 5, 2018

Study Completion

December 1, 2019

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

all collected IPD, all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP
More information

Locations