NCT03396016

Brief Summary

Factor V is a coagulation cofactor that is primarily produced by the liver. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may be a reliable biomarker for hepatic function after LT. Therefore, the aim of this study is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Patients undergoing LT at the University Health Network will have plasmatic Factor V levels measured during postoperative week 1. Patients will be followed up to 12 months. The study outcomes will be early graft dysfunction, and graft and patient survival. Graft loss will be defined as need for retransplantation in the study period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 27, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

December 27, 2017

Last Update Submit

November 7, 2022

Conditions

Liver Transplant Failure

Outcome Measures

Primary Outcomes (3)

  • Factor V plasma level

    Factor V plasma level

    day 1

  • Factor V plasma level

    Factor V plasma level

    day 3

  • Factor V plasma level

    Factor V plasma level

    Day 5

Secondary Outcomes (6)

  • Graft survival

    3 months

  • Graft survival

    6 months

  • Graft survival

    12 months

  • Patient survival

    3 months

  • Patient survival

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Factor V

liver transplant patients having Factor V levels measured during their first postoperative week.

Eligibility Criteria

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

All adult patients awaiting a liver transplantation at University Health Network

You may qualify if:

  • Listed for a deceased donor liver transplant at University Health Network
  • Able and willing to provide informed consent

You may not qualify if:

  • Patients unable to provide informed consent
  • Recipients of live donor liver transplantation
  • Re-transplants
  • Recipients of multiple organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital (University Health Network)

Toronto, Ontario, M5G 2N2, Canada

Location

Study Officials

  • Gonzalo Sapisochin, MD

    Surgical staff

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2017

First Posted

January 10, 2018

Study Start

April 18, 2018

Primary Completion

April 10, 2021

Study Completion

February 28, 2023

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)