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

NCT03723317 | Completed

• 1 other identifier: #0003
• Study Type: observational
• Target: 1,782
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cirrhosis; Liver Failure; Liver Diseases; Transplant Failure

Outcome Measures

Primary Outcomes (1)

• Five-year post-transplant graft survival

  Number of participants experiencing a graft loss for any reason

  5 years

Secondary Outcomes (1)

• Re-transplant rate

  5 years

Study Arms (2)

Training liver transplantation

Patients consecutively transplanted in four European collaborative LT Centres (Ancona, Brussels, Rome Sapienza, and Padua) (N=1,262)

Procedure: Liver transplantation

Validation liver transplantation

Patients consecutively transplanted in the Karolinska Institute (N=520)

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

First deceased-donor liver transplantation

Training liver transplantation; Validation liver transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients transplanted for any liver pathology undergoing a first transplant.

You may qualify if:

• First transplant
• adult (\>18 years)

You may not qualify if:

• living donation
• re-transplant
• combined transplant
• domino transplant
• paediatric transplant

Sponsors & Collaborators

• European Hepatocellular Cancer Liver Transplant Group: lead

Study Sites (1)

UCL

Brussels, Belgium

Location

Related Publications (1)

• Lai Q, Melandro F, Nowak G, Nicolini D, Iesari S, Fasolo E, Mennini G, Romano A, Mocchegiani F, Ackenine K, Polacco M, Marinelli L, Ciccarelli O, Zanus G, Vivarelli M, Cillo U, Rossi M, Ericzon BG, Lerut J. The role of the comprehensive complication index for the prediction of survival after liver transplantation. Updates Surg. 2021 Feb;73(1):209-221. doi: 10.1007/s13304-020-00878-4. Epub 2020 Sep 6.

  PMID: 32892294 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Liver Failure; Liver Diseases

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatic Insufficiency

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Quirino Lai, MD PhD

  UCL Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: January 15, 2018
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)