Developing Prediction Models for Allograft Failure After Liver Transplantation (IMPROVEMENT)
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ClinicalTrials.gov Identifier: NCT05289609 |
Recruitment Status : Unknown
Verified March 2022 by Prof. Alfonso Avolio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Recruitment status was: Not yet recruiting
First Posted : March 21, 2022
Last Update Posted : March 21, 2022
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Prompt identification of allograft failure (AF) is highly desirable to address patients to liver retransplantation, in order to maximize results and preserve patients safety.
Recently, sophisticated kinetic models became available, offering the possibility to predict 90-day AF with unprecedented accuracy, by computing data from the first 10 days after liver transplant (LT).
The growing utilization of extended criteria and cardiac death donors stimulates the transplant community to further refine such predictive models and validate them on a larger scale population of patients across the nations.
This study aims to develop new algorithms for the timely prediction of AF at 90 and 365 days using a prospective international cohort from high-volume centers, to validate them on a large retrospective cohort, to identify the best time for retransplantation, to stratify the risk of AF according to the graft type (i.e. DBD, ECD, DCD, LD), to weigh the effect of risk-mitigation strategies, and to assess the correlation with post-LT morbidity and mortality.
Condition or disease | Intervention/treatment |
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Liver Transplant Disorder | Procedure: Liver Transplantation |
Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Official Title: | International Multicenter Prospective, Non-competitive, Observational Study to Validate and Optimize Prediction Models of 90-day and 1-year Allograft Failure After Liver Transplantation |
Estimated Study Start Date : | April 1, 2022 |
Estimated Primary Completion Date : | December 1, 2023 |
Estimated Study Completion Date : | April 1, 2024 |
Group/Cohort | Intervention/treatment |
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Prospective Cohort
Liver Transplant Recipients from High-volume centers (i.e., performing >= 65 LTs per year)
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Procedure: Liver Transplantation
Individuals with end-stage liver disease will be subjected to liver transplantation from deceased or living donors |
Retrospective Cohort
Liver Transplant Recipients from Low-to-medium volume centers (i.e., performing <65 LTs per year) and High-volume centers
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Procedure: Liver Transplantation
Individuals with end-stage liver disease will be subjected to liver transplantation from deceased or living donors |
- Allograft failure [ Time Frame: within 90 days after liver transplantation ]the irreversible loss of graft function leading to retransplantation or patient death
- Allograft failure [ Time Frame: within 365 days after liver transplantation ]the irreversible loss of graft function leading to retransplantation or patient death
- Time to retransplantation [ Time Frame: 365 days ]The time lapsed from the first to the second liver transplant
- Complications after liver transplantation [ Time Frame: 90 days ]The development of post-LT complications such as acute kidney injury, sepsis, respiratory failure, vascular thrombosis
- Ischemic cholangiopathy [ Time Frame: 365 days ]The development of ischemia-related changes in the biliary ducts of the grafts that require active treatment (from antibiotics up to retransplantation)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | based on self-representation of gender identity |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
5000 patients from 80 liver transplant centers (target size), divided in two cohorts:
- Prospective: 2000 patients from 40 high-volume centers (performing ≥65 LT a year); 50 consecutive transplants; 365-day follow-up period.
- Retrospective: 3000 patients from 40 medium-low volume centers (performing <65 LT a year); data collection of LTs performed between 31/12/2019 and 1/1/2017; 75 cases per center.
High-volume centers will be allowed to enroll patients in the retrospective cohort too, enrolling a total of 125 transplants (50 prospective and 75 retrospective ).
Each cohort can accommodate >40 centers without altering the balanced study design (once the 40-center target has been reached, each cohort can grow by a 20% extent above the target without altering the balance).
Inclusion Criteria:
- Adult recipients (≥18 years)
- First transplant (retransplant cases should be enrolled if the first transplant is part of the study)
- DBD grafts
- DCD grafts (controlled and uncontrolled)
- DBD and DCD grafts managed by perfusion machines
- Living donor grafts (both left lobe and right lobe grafts) transplanted into adult recipients.
- Split liver grafts (both left lobe and right lobe grafts) transplanted into adult recipients.
Exclusion Criteria:
- Combined grafts (e.g., liver-kidney, liver-heart, liver-pancreas, multi-visceral grafts)
- Domino grafts
- Heterotopic grafts
- Double grafts
- Recipients undergoing liver transplants for cholangiocarcinoma and colorectal liver metastases
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): NCT05289609
Contact: Alfonso W Avolio | 00390630151 | alfonso.avolio@policlinicogemelli.it | |
Contact: Gabriele Spoletini | 00390630154955 | gabriele.spoletini@policlinicogemelli.it |
Principal Investigator: | Vatche Agopian | University of California, Los Angeles | |
Principal Investigator: | Alfonso W Avolio | Fondazione Policlinico universitario Agostino Gemelli IRCCS, Rome, Italy |
Responsible Party: | Prof. Alfonso Avolio, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
ClinicalTrials.gov Identifier: | NCT05289609 |
Other Study ID Numbers: |
4571 |
First Posted: | March 21, 2022 Key Record Dates |
Last Update Posted: | March 21, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Liver transplantation Retransplantation Allograft failure End-stage liver disease |
Graft loss Patient survival Ischemic cholangiopathy |