Clinical trial NCT03396016: Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation
Official title: Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant Failure
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients awaiting a liver transplantation at University Health Network

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Factor V plasma level
timeFrame: day 1
measure: Factor V plasma level
timeFrame: day 3
measure: Factor V plasma level
timeFrame: Day 5
Secondary outcomes:
measure: Graft survival
timeFrame: 3 months
measure: Graft survival
timeFrame: 6 months
measure: Graft survival
timeFrame: 12 months
measure: Patient survival
timeFrame: 3 months
measure: Patient survival
timeFrame: 6 months
measure: Patient survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital (University Health Network)
state: Ontario
Study officials:
affiliation: Surgical staff
name: Gonzalo Sapisochin, MD
role: PRINCIPAL_INVESTIGATOR
References: