Liver Transplant FailureNCT03396016
Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation
An observational study of Liver Transplant Failure, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Failure
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2018to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients awaiting a liver transplantation at University Health Network
Who may be able to join
- Listed for a deceased donor liver transplant at University Health Network
- Able and willing to provide informed consent
Who cannot join
- Patients unable to provide informed consent
- Recipients of live donor liver transplantation
- Re-transplants
- Recipients of multiple organs
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital (University Health Network)
Toronto, Ontario, M5G 2N2
About this study
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Factor V | liver transplant patients having Factor V levels measured during their first postoperative week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factor V plasma level
Factor V plasma level
Measured: day 1
Factor V plasma level
Factor V plasma level
Measured: day 3
Factor V plasma level
Factor V plasma level
Measured: Day 5
Secondary outcomes (6)
Graft survival
graft survival
Measured: 3 months
Graft survival
graft survival
Measured: 6 months
Graft survival
graft survival
Measured: 12 months
Patient survival
patient survival
Measured: 3 months
Patient survival
patient survival
Measured: 6 months
Patient survival
patient survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start18 Apr 2018
- Primary completion10 Apr 2021
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant FailureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gonzalo Sapisochin, MD, Principal investigator, Surgical staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396016
- Sponsor's protocol ID
- 17-6090
- Status last verified
- Nov 2022
- First submitted
- 27 Dec 2017
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation
- ClinicalTrials.gov ID
- NCT03396016
- Acronym / sponsor ID
- 17-6090
- Conditions
- Liver Transplant Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Factor V | – | –liver transplant patients having Factor V levels measured during their first postoperative week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients awaiting a liver transplantation at University Health Network
Key inclusion criteria (2 listed)
- Listed for a deceased donor liver transplant at University Health Network
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- Patients unable to provide informed consent
- Recipients of live donor liver transplantation
- Re-transplants
- Recipients of multiple organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Graft survival
Time frame: 3 months
Graft survival
Time frame: 6 months
Graft survival
Time frame: 12 months
Patient survival
Time frame: 3 months
Patient survival
Time frame: 6 months
Patient survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonzalo Sapisochin, MD principal investigator
Surgical staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Failure, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factor V plasma level (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.