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

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ClinicalTrials.gov Identifier: NCT03396016
Recruitment Status : Enrolling by invitation
First Posted : January 10, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date December 27, 2017
First Posted Date January 10, 2018
Last Update Posted Date October 11, 2018
Actual Study Start Date April 18, 2018
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2018)
  • Factor V plasma level [ Time Frame: day 1 ]
    Factor V plasma level
  • Factor V plasma level [ Time Frame: day 3 ]
    Factor V plasma level
  • Factor V plasma level [ Time Frame: Day 5 ]
    Factor V plasma level
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03396016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 4, 2018)
  • Graft survival [ Time Frame: 3 months ]
    graft survival
  • Graft survival [ Time Frame: 6 months ]
    graft survival
  • Graft survival [ Time Frame: 12 months ]
    graft survival
  • Patient survival [ Time Frame: 3 months ]
    patient survival
  • Patient survival [ Time Frame: 6 months ]
    patient survival
  • Patient survival [ Time Frame: 12 months ]
    patient survival
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All adult patients awaiting a liver transplantation at University Health Network
Condition Liver Transplant Failure
Intervention Not Provided
Study Groups/Cohorts Factor V
liver transplant patients having Factor V levels measured during their first postoperative week.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: January 4, 2018)
140
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2020
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03396016
Other Study ID Numbers 17-6090
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Gonzalo Sapisochin, MD Surgical staff
PRS Account University Health Network, Toronto
Verification Date October 2018