Institutional Registry of Liver Transplantation

NCT ID: NCT02839616

Last Updated: 2016-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-07-31

Brief Summary

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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

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Conditions

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Liver Transplantation Clinical Registry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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orthotopic liver transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital El Cruce

OTHER

Sponsor Role lead

Responsible Party

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Liliana Paloma Rojas Saunero

Research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liliana P Rojas Saunero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital El Cruce

Locations

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Hospital de Alta Complejidad El Cruce

Provincia Florencio Varela, Buenos Aires, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Liliana P Rojas Saunero, MD

Role: CONTACT

+54 11 4210 9000 ext. 2760

Federico G Villamil, MD

Role: CONTACT

+54 11 4210 9000 ext. 2760

Facility Contacts

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Liliana P Rojas, MD

Role: primary

11 4210 9000 ext. 2760

Federico G Villamil, MD

Role: backup

11 4210 9000 ext. 2760

References

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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.

Reference Type BACKGROUND
PMID: 12694047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23481320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23546766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15760420 (View on PubMed)

Other Identifiers

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120716/1

Identifier Type: -

Identifier Source: org_study_id

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