Liver TransplantationIRLTNCT02839616
Institutional Registry of Liver Transplantation
An observational study of Liver Transplantation and Clinical Registry, run by Hospital El Cruce at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplantation, Clinical Registry
- What is being tested?
- orthotopic liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteArgentina
- Study dates
- Jul 2016to Jul 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic liver disease or acute liver failure who are candidates for liver transplantation.
Who may be able to join
- Patients with indication for liver transplantation
- Patients who are followed by the Liver Transplantation Unit of Hospital El Cruce
Who cannot join
- Patients who deny to participate after the informed consent process.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital de Alta Complejidad El Cruce
Provincia Florencio Varela, Buenos Aires, B1888AAE
Liliana P Rojas, MD, 11 4210 9000 ext. 2760, palolili@gmail.com
Federico G Villamil, MD, 11 4210 9000 ext. 2760, fgvillamil@hotmail.com
About this study
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.
- Conditions
- Liver Transplantation, Clinical Registry
- Being tested
- orthotopic liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthotopic liver transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liliana Paloma Rojas Saunero, Hospital El Cruce
- Investigators
- Liliana P Rojas Saunero, MD, Principal investigator, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839616
- Sponsor's protocol ID
- 120716/1
- Acronym
- IRLT
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12694047Leppke 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.
PubMed 23481320Koller 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.
PubMed 23546766Schaubel 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.
PubMed 15760420
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Registry of Liver Transplantation
- ClinicalTrials.gov ID
- NCT02839616
- Acronym / sponsor ID
- IRLT / 120716/1
- Conditions
- Liver Transplantation, Clinical Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease or acute liver failure who are candidates for liver transplantation.
Key inclusion criteria (2 listed)
- Patients with indication for liver transplantation
- Patients who are followed by the Liver Transplantation Unit of Hospital El Cruce
Key exclusion criteria (1 listed)
- Patients who deny to participate after the informed consent process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthotopic liver transplantation | Procedure or surgery | – |
Primary outcome
Time to mortality
Time frame: 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.
1 secondary outcome
Time to retransplantation
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Background: PubMed 12694047Dickinson 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.
- Background: PubMed 23481320Leppke 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.
- Background: PubMed 23546766Koller 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.
- Background: PubMed 15760420Schaubel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liliana P Rojas Saunero, MD principal investigator
Hospital El Cruce
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Clinical Registry, run by Hospital El Cruce at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liliana P Rojas Saunero, MD (+54 11 4210 9000 ext. 2760, palolili@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839616, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.