NCT02873507

Brief Summary

A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room.

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 May 2018

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

August 4, 2016

Last Update Submit

January 31, 2018

Conditions

Fatty LiverSteatosis of Liver

Keywords

transplantation, liver

Outcome Measures

Primary Outcomes (1)

  • Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation

    Amount of fat measured in the donor liver prior to transplant surgery using MRI scan

    Measured immediately prior to liver transplant

Secondary Outcomes (3)

  • Comparison of steatosis percentages provided by biopsy to MRI results

    Baseline

  • Length of hospitalization of transplant recipient

    Days to hospital discharge, approximately 2 weeks

  • Mortality of liver transplant recipient at 1 year post transplantation

    1 year

Study Arms (1)

MRI of donor liver

EXPERIMENTAL

MRI evaluation of graft steatosis in donor liver prior to transplantation

Other: MRI of donor liver prior to transplant

Interventions

MRI of donor liver prior to transplantOTHER

MRI of the on ice donor liver within the transport cooler on its way to the operating room

MRI of donor liver

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are scheduled to orthoptic liver transplant

You may not qualify if:

  • Patient's who do not agree to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Bret D Alvis, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 19, 2016

Study Start

May 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share