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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723317
• Other study ID #: #0003
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: October 15, 2018

Study information

• Verified date: October 2018
• Source: European Hepatocellular Cancer Liver Transplant Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1782
• Est. completion date: October 15, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• First transplant

• adult (>18 years)

Exclusion Criteria:

• living donation

• re-transplant

• combined transplant

• domino transplant

• paediatric transplant

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Diseases
• Liver Failure
• Transplant Failure

Intervention

Procedure:
• Liver transplantation
First deceased-donor liver transplantation

Locations

Country	Name	City	State
Belgium	UCL	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
European Hepatocellular Cancer Liver Transplant Group

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Five-year post-transplant graft survival	Number of participants experiencing a graft loss for any reason	5 years
Secondary	Re-transplant rate	Number of participants experiencing a re-transplant for any reason	5 years