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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

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Factor V plasma level [ Time Frame: day 1 ]
    Factor V plasma level

  2. Factor V plasma level [ Time Frame: day 3 ]
    Factor V plasma level

  3. Factor V plasma level [ Time Frame: Day 5 ]
    Factor V plasma level


Secondary Outcome Measures :
  1. Graft survival [ Time Frame: 3 months ]
    graft survival

  2. Graft survival [ Time Frame: 6 months ]
    graft survival

  3. Graft survival [ Time Frame: 12 months ]
    graft survival

  4. Patient survival [ Time Frame: 3 months ]
    patient survival

  5. Patient survival [ Time Frame: 6 months ]
    patient survival

  6. Patient survival [ Time Frame: 12 months ]
    patient survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients awaiting a liver transplantation at University Health Network
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396016


Locations
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Canada, Ontario
Toronto General Hospital (University Health Network)
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Gonzalo Sapisochin, MD Surgical staff

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03396016     History of Changes
Other Study ID Numbers: 17-6090
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No