Liver Transplant DisorderNCT04530240
Equity and Efficacy of Allocation Priority for Liver Transplantation Patients With MELD≥30 in Italy
An observational study of Liver Transplant Disorder and HCC, run by University of Bologna.
Trial summary
In Italy, since August 2014, liver transplantation (LT) candidates with MELD≥30 receive a priority allocation consenting them to access in an organ sharing macroarea. The primary intent of this policy is to minimize the higher risk of waiting list dropout observed in these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplant Disorder, HCC
- What is being tested?
- Liver Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 4,238 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2010to 31 Dec 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: 4,238 LT patients registered from August 2010 to July 2018 have been initially enrolled for the analysis (Bologna=961, Pisa=980, Turin=897, Milan Niguarda=859, Rome Sapienza=268, Rome Cattolica=273), and categorized in an ERA-1 Group (n=2,225; before macroarea priority allocation), and an ERA-2 Group (n=2,013; after macroarea priority allocation).
Who may be able to join
- LT patients registered from August 2010 to July 2018
Who cannot join
- LT patients registered before August 2010 and after July 2018
- Data not available for analysis
About this study
Official title: Impact of National MELD ≥ 30 Priority Allocation System on Dropout and Post-Transplant Survival Rates in Italy: A Retrospective Competing-Risk Analysis
In Italy, since August 2014, liver transplantation (LT) candidates with MELD≥30 receive a priority allocation consenting them to access in an organ sharing macroarea. The primary intent of this policy is to minimize the higher risk of waiting list dropout observed in these patients. Another objective of this allocation strategy is to reduce the waiting time, thus performing the LT in better clinical conditions. This multicentre retrospective national study aims to evaluate several parameters of efficacy and equity, such as waiting time in the list, dropout rate, and graft survival, in two eras of enlisted patients, before and after the introduction of the macroarea sharing policy in Italy. With the intent to minimize the presence of possible selection biases, the two groups were matched trough Propensity Score Matching (PSM).
Read the detailed description
A retrospective multi-centre study involving six Italian transplant centres was performed using prospectively collected databases from each participating centre, registering MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up.
Study population was divided in two groups according to the time of waiting list before or after the introduction of MELD ≥ 30 allocation scheme: ERA-1 Group (August 2010 - July 2014), and ERA-2 Group (August 2014 - July 2018).
Primary endpoint was waiting list time across different eras in patients above and below MELD ≥ 30 cutoff. Secondary endpoints were dropout rate as well as patient and graft survival.
- Conditions
- Liver Transplant Disorder, HCC
- Being tested
- Liver Transplantation
- Keywords
- Allocation System, Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantationProcedure or surgery
Use prospectively collected databases from each participate centre, register MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up.
| Study group | Role | What they receive |
|---|---|---|
| ERA-1 Group | Before the introduction of the MELD≥30 allocation scheme August 2010 - July 2014 Receives: Procedure: Liver Transplantation | |
| ERA-2 Group | After the introduction of the MELD≥30 allocation scheme August 2014 - July 2018 Receives: Procedure: Liver Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival
Survival since waiting list and after liver transplantation
Measured: 5 year
Secondary outcomes (1)
Graft Survival
Survival of the graft since liver transplantation
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Aug 2010
- Primary completion31 Aug 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant DisorderStudies 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
- Retrospective
- Enrolment
- 4,238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, University of Pisa, A.O.U. Città della Salute e della Scienza, Niguarda Hospital, Catholic University of the Sacred Heart
- Responsible party
- Principal investigator, Matteo Ravaioli, Professor, University of Bologna
- Investigators
- Matteo Ravaioli, Professor, Principal investigator, Sant'Orsola-Malpighi Hospital, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530240
- Sponsor's protocol ID
- Reg.Pg284644
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ravaioli M, Grazi GL, Ballardini G, Cavrini G, Ercolani G, Cescon M, Zanello M, Cucchetti A, Tuci F, Del Gaudio M, Varotti G, Vetrone G, Trevisani F, Bolondi L, Pinna AD. Liver transplantation with the Meld system: a prospective study from a single European center. Am J Transplant. 2006 Jul;6(7):1572-7. doi: 10.1111/j.1600-6143.2006.01354.x.
PubMed 16827857Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D'Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001 Feb;33(2):464-70. doi: 10.1053/jhep.2001.22172.
PubMed 11172350Nekrasov V, Matsuoka L, Rauf M, Kaur N, Cao S, Groshen S, Alexopoulos SP. National Outcomes of Liver Transplantation for Model for End-Stage Liver Disease Score >/=40: The Impact of Share 35. Am J Transplant. 2016 Oct;16(10):2912-2924. doi: 10.1111/ajt.13823. Epub 2016 May 13.
PubMed 27063579Goldberg DS, Levine M, Karp S, Gilroy R, Abt PL. Share 35 changes in center-level liver acceptance practices. Liver Transpl. 2017 May;23(5):604-613. doi: 10.1002/lt.24749.
PubMed 28240804Weismuller TJ, Fikatas P, Schmidt J, Barreiros AP, Otto G, Beckebaum S, Paul A, Scherer MN, Schmidt HH, Schlitt HJ, Neuhaus P, Klempnauer J, Pratschke J, Manns MP, Strassburg CP. Multicentric evaluation of model for end-stage liver disease-based allocation and survival after liver transplantation in Germany--limitations of the 'sickest first'-concept. Transpl Int. 2011 Jan;24(1):91-9. doi: 10.1111/j.1432-2277.2010.01161.x. Epub 2010 Sep 3.
PubMed 20819196Habib S, Berk B, Chang CC, Demetris AJ, Fontes P, Dvorchik I, Eghtesad B, Marcos A, Shakil AO. MELD and prediction of post-liver transplantation survival. Liver Transpl. 2006 Mar;12(3):440-7. doi: 10.1002/lt.20721.
PubMed 16498643Nicolas CT, Nyberg SL, Heimbach JK, Watt K, Chen HS, Hathcock MA, Kremers WK. Liver transplantation after share 35: Impact on pretransplant and posttransplant costs and mortality. Liver Transpl. 2017 Jan;23(1):11-18. doi: 10.1002/lt.24641. Epub 2016 Dec 5.
PubMed 27658200Ravaioli M, Grande G, Di Gioia P, Cucchetti A, Cescon M, Ercolani G, Del Gaudio M, Morelli C, Pinna AD. Risk Avoidance and Liver Transplantation: A Single-center Experience in a National Network. Ann Surg. 2016 Nov;264(5):778-786. doi: 10.1097/SLA.0000000000001887.
PubMed 27429038Nagai S, Chau LC, Schilke RE, Safwan M, Rizzari M, Collins K, Yoshida A, Abouljoud MS, Moonka D. Effects of Allocating Livers for Transplantation Based on Model for End-Stage Liver Disease-Sodium Scores on Patient Outcomes. Gastroenterology. 2018 Nov;155(5):1451-1462.e3. doi: 10.1053/j.gastro.2018.07.025. Epub 2018 Jul 26.
PubMed 30056096Kwong AJ, Goel A, Mannalithara A, Kim WR. Improved posttransplant mortality after share 35 for liver transplantation. Hepatology. 2018 Jan;67(1):273-281. doi: 10.1002/hep.29301. Epub 2017 Nov 13.
PubMed 28586179Beal EW, Black SM, Mumtaz K, Hayes D Jr, El-Hinnawi A, Washburn K, Tumin D. High Center Volume Does Not Mitigate Risk Associated with Using High Donor Risk Organs in Liver Transplantation. Dig Dis Sci. 2017 Sep;62(9):2578-2585. doi: 10.1007/s10620-017-4639-2. Epub 2017 Jun 1.
PubMed 28573507Kang S, Little RJ, Kaciroti N. Missing not at random models for masked clinical trials with dropouts. Clin Trials. 2015 Apr;12(2):139-48. doi: 10.1177/1740774514566662. Epub 2015 Jan 27.
PubMed 25627429Caliendo M, Kopeinig S. Some practical guidance for the implementation of propensity score matching. J Econ Surv. 2008; 22:31-72
Austin PC, Lee DS, Fine JP. Introduction to the Analysis of Survival Data in the Presence of Competing Risks. Circulation. 2016 Feb 9;133(6):601-9. doi: 10.1161/CIRCULATIONAHA.115.017719.
PubMed 26858290Nekrasov V, Matsuoka L, Kaur N, Pita A, Whang G, Cao S, Groshen S, Alexopoulos S. Improvement in the Outcomes of MELD >/= 40 Liver Transplantation: An Analysis of 207 Consecutive Transplants in a Highly Competitive DSA. Transplantation. 2017 Oct;101(10):2360-2367. doi: 10.1097/TP.0000000000001738.
PubMed 28319564
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of National MELD ≥ 30 Priority Allocation System on Dropout and Post-Transplant Survival Rates in Italy: A Retrospective Competing-Risk Analysis
- ClinicalTrials.gov ID
- NCT04530240
- Acronym / sponsor ID
- Reg.Pg284644
- Conditions
- Liver Transplant Disorder, HCC
- Keywords
- Allocation System, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,238 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, University of Pisa, A.O.U. Città della Salute e della Scienza, Niguarda Hospital, Catholic University of the Sacred Heart
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Aug 2020 (actual)
- 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.
In Italy, since August 2014, liver transplantation (LT) candidates with MELD≥30 receive a priority allocation consenting them to access in an organ sharing macroarea. The primary intent of this policy is to minimize the higher risk of waiting list dropout observed in these patients. Another objective of this allocation strategy is to reduce the waiting time, thus performing the LT in better clinical conditions. This multicentre retrospective national study aims to evaluate several parameters of efficacy and equity, such as waiting time in the list, dropout rate, and graft survival, in two eras of enlisted patients, before and after the introduction of the macroarea sharing policy in Italy. With the intent to minimize the presence of possible selection biases, the two groups were matched trough Propensity Score Matching (PSM).
Detailed description
A retrospective multi-centre study involving six Italian transplant centres was performed using prospectively collected databases from each participating centre, registering MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up.
Study population was divided in two groups according to the time of waiting list before or after the introduction of MELD ≥ 30 allocation scheme: ERA-1 Group (August 2010 - July 2014), and ERA-2 Group (August 2014 - July 2018).
Primary endpoint was waiting list time across different eras in patients above and below MELD ≥ 30 cutoff. Secondary endpoints were dropout rate as well as patient and graft survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERA-1 Group | – | Procedure: Liver TransplantationBefore the introduction of the MELD≥30 allocation scheme August 2010 - July 2014 |
| ERA-2 Group | – | Procedure: Liver TransplantationAfter the introduction of the MELD≥30 allocation scheme August 2014 - July 2018 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 4,238 LT patients registered from August 2010 to July 2018 have been initially enrolled for the analysis (Bologna=961, Pisa=980, Turin=897, Milan Niguarda=859, Rome Sapienza=268, Rome Cattolica=273), and categorized in an ERA-1 Group (n=2,225; before macroarea priority allocation), and an ERA-2 Group (n=2,013; after macroarea priority allocation).
Key inclusion criteria (1 listed)
- LT patients registered from August 2010 to July 2018
Key exclusion criteria (2 listed)
- LT patients registered before August 2010 and after July 2018
- Data not available for analysis
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 |
|---|---|---|
| Liver TransplantationUse prospectively collected databases from each participate centre, register MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up. | Procedure or surgery | ERA-1 Group, ERA-2 Group |
Primary outcome
Patient Survival
Time frame: 5 year
Survival since waiting list and after liver transplantation
1 secondary outcome
Graft Survival
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Background: PubMed 16827857Ravaioli M, Grazi GL, Ballardini G, Cavrini G, Ercolani G, Cescon M, Zanello M, Cucchetti A, Tuci F, Del Gaudio M, Varotti G, Vetrone G, Trevisani F, Bolondi L, Pinna AD. Liver transplantation with the Meld system: a prospective study from a single European center. Am J Transplant. 2006 Jul;6(7):1572-7. doi: 10.1111/j.1600-6143.2006.01354.x.
- Background: PubMed 11172350Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D'Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001 Feb;33(2):464-70. doi: 10.1053/jhep.2001.22172.
- Background: PubMed 27063579Nekrasov V, Matsuoka L, Rauf M, Kaur N, Cao S, Groshen S, Alexopoulos SP. National Outcomes of Liver Transplantation for Model for End-Stage Liver Disease Score >/=40: The Impact of Share 35. Am J Transplant. 2016 Oct;16(10):2912-2924. doi: 10.1111/ajt.13823. Epub 2016 May 13.
- Background: PubMed 28240804Goldberg DS, Levine M, Karp S, Gilroy R, Abt PL. Share 35 changes in center-level liver acceptance practices. Liver Transpl. 2017 May;23(5):604-613. doi: 10.1002/lt.24749.
- Background: PubMed 20819196Weismuller TJ, Fikatas P, Schmidt J, Barreiros AP, Otto G, Beckebaum S, Paul A, Scherer MN, Schmidt HH, Schlitt HJ, Neuhaus P, Klempnauer J, Pratschke J, Manns MP, Strassburg CP. Multicentric evaluation of model for end-stage liver disease-based allocation and survival after liver transplantation in Germany--limitations of the 'sickest first'-concept. Transpl Int. 2011 Jan;24(1):91-9. doi: 10.1111/j.1432-2277.2010.01161.x. Epub 2010 Sep 3.
- Background: PubMed 16498643Habib S, Berk B, Chang CC, Demetris AJ, Fontes P, Dvorchik I, Eghtesad B, Marcos A, Shakil AO. MELD and prediction of post-liver transplantation survival. Liver Transpl. 2006 Mar;12(3):440-7. doi: 10.1002/lt.20721.
- Background: PubMed 27658200Nicolas CT, Nyberg SL, Heimbach JK, Watt K, Chen HS, Hathcock MA, Kremers WK. Liver transplantation after share 35: Impact on pretransplant and posttransplant costs and mortality. Liver Transpl. 2017 Jan;23(1):11-18. doi: 10.1002/lt.24641. Epub 2016 Dec 5.
- Background: PubMed 27429038Ravaioli M, Grande G, Di Gioia P, Cucchetti A, Cescon M, Ercolani G, Del Gaudio M, Morelli C, Pinna AD. Risk Avoidance and Liver Transplantation: A Single-center Experience in a National Network. Ann Surg. 2016 Nov;264(5):778-786. doi: 10.1097/SLA.0000000000001887.
- Background: PubMed 30056096Nagai S, Chau LC, Schilke RE, Safwan M, Rizzari M, Collins K, Yoshida A, Abouljoud MS, Moonka D. Effects of Allocating Livers for Transplantation Based on Model for End-Stage Liver Disease-Sodium Scores on Patient Outcomes. Gastroenterology. 2018 Nov;155(5):1451-1462.e3. doi: 10.1053/j.gastro.2018.07.025. Epub 2018 Jul 26.
- Background: PubMed 28586179Kwong AJ, Goel A, Mannalithara A, Kim WR. Improved posttransplant mortality after share 35 for liver transplantation. Hepatology. 2018 Jan;67(1):273-281. doi: 10.1002/hep.29301. Epub 2017 Nov 13.
- Background: PubMed 28573507Beal EW, Black SM, Mumtaz K, Hayes D Jr, El-Hinnawi A, Washburn K, Tumin D. High Center Volume Does Not Mitigate Risk Associated with Using High Donor Risk Organs in Liver Transplantation. Dig Dis Sci. 2017 Sep;62(9):2578-2585. doi: 10.1007/s10620-017-4639-2. Epub 2017 Jun 1.
- Background: PubMed 25627429Kang S, Little RJ, Kaciroti N. Missing not at random models for masked clinical trials with dropouts. Clin Trials. 2015 Apr;12(2):139-48. doi: 10.1177/1740774514566662. Epub 2015 Jan 27.
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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.
Matteo Ravaioli, Professor principal investigator
Sant'Orsola-Malpighi Hospital, University of Bologna
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Disorder and HCC, run by University of Bologna.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Survival (time frame: 5 year). 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 NCT04530240, which also lists 25 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 28 Aug 2020.