Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Transplant Failure

Detailed Description

There is no widely accepted biomarker to assess hepatic function after Liver Transplantation (LT). Factor V is a coagulation cofactor that is primarily produced by the liver. Factor V has a short half-life and its production does not depend on vitamin K, relying mainly on liver function. These singular characteristics make Factor V plasmatic levels strictly linked to liver function. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may predict graft dysfunction after LT, and become a reliable biomarker for hepatic function after LT. Therefore, the aim is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Participants (patients undergoing LT at the University Health Network) will have plasmatic Factor V levels measured on postoperative days (POD) 1º, 2º, 3º, 5º and 7º. Participants will be followed up to 12 months. The study primary outcome will be early graft dysfunction as defined by Olthoff et al. Secondary outcomes will be 3-, 6- and 12-months graft and patient survival. Graft loss will be defined as need for retransplantation in the study period. Potential confounders will be assessed in a multivariate regression model. No other intervention will be done to the patients. The results of this study may validate the use of this biomarker for graft dysfunction and mortality after LT. These results will impact LT research and direct patient care.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital (University Health Network)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients awaiting a liver transplantation at University Health Network

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Factor V; liver transplant patients having Factor V levels measured during their first postoperative week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft survival	graft survival	3 months
Graft survival	graft survival	6 months
Graft survival	graft survival	12 months
Patient survival	patient survival	3 months
Patient survival	patient survival	6 months
Patient survival	patient survival	12 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Gonzalo Sapisochin, MD, Surgical staff

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): April 10, 2021
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 17-6090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No