Institutional Registry of Liver Transplantation

Liver Transplantation Clinical Trial

— IRLT  

Official title:

Institutional Registry of Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02839616
• Other study ID #: 120716/1
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2016
• Last updated: July 18, 2016
• Start date: July 2016
• Est. completion date: July 2020

Study information

• Verified date: July 2016
• Source: Hospital El Cruce
• Contact: Liliana P Rojas Saunero, MD
• Phone: +54 11 4210 9000
• Email: palolili[@]gmail.com
• Is FDA regulated: No
• Health authority: Argentina: Human Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2020
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clinical Registry
• Liver Transplantation

Intervention

Procedure:
• orthotopic liver transplantation

Locations

Country	Name	City	State
Argentina	Hospital de Alta Complejidad El Cruce	Provincia Florencio Varela	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital El Cruce

Country where clinical trial is conducted

Argentina, 

References & Publications (4)

Dickinson DM, Ellison MD, Webb RL. Data sources and structure. Am J Transplant. 2003;3 Suppl 4:13-28. Review. — View Citation

Koller MT, van Delden C, Müller NJ, Baumann P, Lovis C, Marti HP, Fehr T, Binet I, De Geest S, Bucher HC, Meylan P, Pascual M, Steiger J. Design and methodology of the Swiss Transplant Cohort Study (STCS): a comprehensive prospective nationwide long-term follow-up cohort. Eur J Epidemiol. 2013 Apr;28(4):347-55. doi: 10.1007/s10654-012-9754-y. Epub 2013 Apr 2. — View Citation

Leppke S, Leighton T, Zaun D, Chen SC, Skeans M, Israni AK, Snyder JJ, Kasiske BL. Scientific Registry of Transplant Recipients: collecting, analyzing, and reporting data on transplantation in the United States. Transplant Rev (Orlando). 2013 Apr;27(2):50-6. doi: 10.1016/j.trre.2013.01.002. Epub 2013 Mar 6. Review. — View Citation

Schaubel DE, Dykstra DM, Murray S, Ashby VB, McCullough KP, Dickinson DM, Hulbert-Shearon TE, Webb RL, Wolfe RA. Analytical approaches for transplant research, 2004. Am J Transplant. 2005 Apr;5(4 Pt 2):950-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to mortality	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.	5 years	No
Secondary	Time to retransplantation	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.	5 years	No