Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Post-transplant Survival

Study Overview
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Brief Summary
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In recent years, several scoring systems have been developed aimed at predicting early post-LT graft function. However, many of them showed poor efficacy when long-term survivals were tested. Moreover, the necessity to find an easy-to-use score represents another obstacle, with several scores composed by numerous, difficult to find, variables. Recently, the pre-LT Balance of Risk (BAR) and the post-LT Comprehensive Complication Index (CCI) have been created, but their external validation and integration in this setting is lacking. This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-liver transplant (LT) independent variables, in order to accurately predict long-term graft survival after LT.

Detailed Description
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In the last years, several scoring systems have been developed with the intent to predict waiting-list mortality or early allograft dysfunction (EAD) after liver transplantation (LT). The Model for End-stage Liver Disease (MELD) is recognised as the most accurate liver allograft allocation model by prioritising patients according to the severity of their disease. However, several studies showed that MELD alone failed to predict early and late post-transplant clinical course. Consequently, other scoring systems based on pre-LT or post-LT variables have been developed, with the intent to identify high-risk cases for death, graft loss or re-transplantation (re-LT). Among them, two pre-LT scores, namely the D-MELD and Balance of Risk (BAR), showed to well predict early post-LT survival. Similarly, some post-LT scores were able to estimate EAD, and, thereby, to predict the probabilities of early re-LT and patient death. Interestingly, all of these scores, especially those based on pre-LT variables, resulted in a scarce prediction of long-term (five-year) survivals. Recently, the Comprehensive Complication Index (CCI) has been developed in order to better capture complication rates after surgery. Some reports reported its excellent prognostic ability in different fields. However, up to now, no studies investigated the role of CCI concerning long-term prognostication of graft loss in LT. This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-LT independent variables, in order to accurately predict five-year post-LT graft survival. Both external and internal validations of the score were performed.

Official Title
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Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Long-term Survival After Liver Transplantation

Conditions
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Liver Cirrhosis, Liver Failure, Liver Diseases, Transplant Failure

Intervention / Treatment
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* Procedure: Liver transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First transplant adult (>18 years) Exclusion Criteria: living donation re-transplant combined transplant domino transplant paediatric transplant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training liver transplantation<br>Patients consecutively transplanted in four European collaborative LT Centres (Ancona, Brussels, Rome Sapienza, and Padua) (N=1,262) | Procedure: Liver transplantation<br>* First deceased-donor liver transplantation<br>|
| Validation liver transplantation<br>Patients consecutively transplanted in the Karolinska Institute (N=520) | Procedure: Liver transplantation<br>* First deceased-donor liver transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five-year post-transplant graft survival | Number of participants experiencing a graft loss for any reason | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-transplant rate | Number of participants experiencing a re-transplant for any reason | 5 years |