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

Liver Transplant Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03396016
• Other study ID #: 17-6090
• Status: Active, not recruiting
• Start date: April 18, 2018
• Est. completion date: February 28, 2023

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: February 28, 2023
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant Failure

Locations

Country	Name	City	State
Canada	Toronto General Hospital (University Health Network)	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factor V plasma level	Factor V plasma level	day 1
Primary	Factor V plasma level	Factor V plasma level	day 3
Primary	Factor V plasma level	Factor V plasma level	Day 5
Secondary	Graft survival	graft survival	3 months
Secondary	Graft survival	graft survival	6 months
Secondary	Graft survival	graft survival	12 months
Secondary	Patient survival	patient survival	3 months
Secondary	Patient survival	patient survival	6 months
Secondary	Patient survival	patient survival	12 months