NCT02839616

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 15, 2016

Last Update Submit

July 18, 2016

Conditions

Liver TransplantationClinical Registry

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Time to retransplantation

    5 years

Interventions

orthotopic liver transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic liver disease or acute liver failure who are candidates for liver transplantation.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Alta Complejidad El Cruce

Provincia Florencio Varela, Buenos Aires, B1888AAE, Argentina

RECRUITING

Related Publications (4)

  • 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.

    PMID: 12694047BACKGROUND

  • 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.

    PMID: 23481320BACKGROUND

  • 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.

    PMID: 23546766BACKGROUND

  • 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.

    PMID: 15760420BACKGROUND

Study Officials

  • Liliana P Rojas Saunero, MD

    Hospital El Cruce

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liliana P Rojas Saunero, MD

CONTACT

+54 11 4210 9000palolili@gmail.com

Federico G Villamil, MD

CONTACT

+54 11 4210 9000fgvillamil@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 21, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2020

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

AR(1)