Clinical trial NCT02839616: Institutional Registry of Liver Transplantation
Official title: Institutional Registry of Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Clinical Registry
Lead sponsor: Hospital El Cruce
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease or acute liver failure who are candidates for liver transplantation.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to mortality
timeFrame: 5 years
Secondary outcomes:
measure: Time to retransplantation
timeFrame: 5 years
Other outcomes:
Locations:
city: Provincia Florencio Varela
country: Argentina
facility: Hospital de Alta Complejidad El Cruce
state: Buenos Aires
Study officials:
affiliation: Hospital El Cruce
name: Liliana P Rojas Saunero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dickinson DM, Ellison MD, Webb RL. Data sources and structure. Am J Transplant. 2003;3 Suppl 4:13-28. doi: 10.1034/j.1600-6143.3.s4.3.x. No abstract available.
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.
citation: Koller MT, van Delden C, Muller 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.
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. doi: 10.1111/j.1600-6135.2005.00837.x.