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

NCT ID: NCT03396016

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2023-02-28

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.

Conditions

Liver Transplant Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Factor V

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gonzalo Sapisochin, MD

Role: PRINCIPAL_INVESTIGATOR

Surgical staff

Locations

Toronto General Hospital (University Health Network)

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

17-6090

Identifier Type: -

Identifier Source: org_study_id