Institutional Registry of Liver Transplantation

• Conditions: Liver Transplantation; Clinical Registry

• Registration Number: NCT02839616
• Lead Sponsor: Hospital El Cruce

Brief Summary

The Institutional Registry of Liver Transplantation is a system for data collection related to patients with liver disease who are possible candidates for liver transplantion. This tool was designed by a multidisciplinary team that includes hepatologists, surgeons, informatics and biostatisticians. It intends to collect the information from the clinical evaluation, physical examination, complementary diagnostic methods and laboratory data. The information is captured sistematically, following structured, standardized and monitored processess to ensure the quality of the data obtained.

The aim is to use the available technology to generate a complete database that can be used to answer research questions.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-18
• Last Update Submitted: 2016-07-18
• Study First Posted: 2016-07-21
• Last Update Posted: 2016-07-21
• Primary Completion: 2018-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with indication for liver transplantation
• Patients who are followed by the Liver Transplantation Unit of Hospital El Cruce

Exclusion Criteria

• Patients who deny to participate after the informed consent process.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to mortality	5 years	All patients are followed from the date of the inclusion to the registry, by periodic controls by the hepatologists and through telephones calls by the coordinator nurse, both before and after the transplantation.; Every patient who dies during the 5 years of follow up will count as an event. Patients who are lost to follow up will be censored, in this case we will use the date of the last control or telephone call where he or she was alive.

Secondary Outcome Measures

Name	Time	Method
Time to retransplantation	5 years	We will considerate retransplantation as a competitive risk for death, calculating the time since the date of the transplant until the date of retransplantantion or not during the 5 years of follow up.

Trial Locations

Locations (1)

Hospital de Alta Complejidad El Cruce; 🇦🇷 Provincia Florencio Varela, Buenos Aires, Argentina