Liver TransplantNCT05087550
Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
An observational study of Liver Transplant, run by Methodist Health System at 1 site in United States.
Trial summary
Organ procurement organizations (OPO) have increased organ recovery efficiency and yield and have also reduced organ acquisition charges. The new liver allocation policy came into effect in February 2020 and aims to increase access to organs for waitlist candidates with the greatest severity of illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Liver Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to 9 Aug 2023
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from patients who underwent liver transplantation between February 4th, 2019 - February 4th, 2020, and February 5th, 2020 - February 5th, 2021 will be included in the study.
Who may be able to join
- Age 18 years or older
- Underwent liver transplantation at MDMC between February 4th 2019 - February 4th 2020 and February 5th 2020 - February 5th 2021
Who cannot join
- Below 18 years of age
- Did not undergo liver transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Organ procurement organizations (OPO) have increased organ recovery efficiency and yield and have also reduced organ acquisition charges. The new liver allocation policy came into effect in February 2020 and aims to increase access to organs for waitlist candidates with the greatest severity of illness. The urgent change was driven by the perception that patients were dying because of arbitrary boundaries and inequitable access. Critics of the new policy have highlighted the potential cost implications particularly at an OPO level. A study of five OPOs throughout the United States highlighted an increase in costs ranging from 43% - 206% despite the same volume of livers transplanted. The main reason for the cost appears to lie in organ handling and transport. This mirrors the findings of Puri and colleagues who acknowledged changes to lung transplantation at Barnes Jewish Hospital in the pre- and post-policy eras and reported a substantial decline in local donors. The new lung system has also resulted in a higher organ discard rate and ultimately higher costs. Such data has generated meaningful discussions regarding optimizing organ allocation polices, however, data from individual transplant centers is lacking in the literature. Changes at a transplant center level relating to recipient costs are likely impacted by the new policy, which could be related to patient travel, accommodation, work up etc.
- Conditions
- Liver Transplant
- Being tested
- Liver Transplantation
- Keywords
- Organ Procurement and Transplant Network (OPTN), Liver Allocation Policy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantationProcedure or surgery
Patients who underwent liver transplantation at Methodist Dallas Medical Center
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplantation patients | Not described Receives: Procedure: Liver Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver transplant volume
Measured: 02/04/2019 - 02/05/2021
Cost
Costs related to:
- Transplant volume and organ recovery information
- Transportation costs, distance traveled, travel time
- Personnel costs
- Hospital charges/costs
Measured: 02/04/2019 - 02/05/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start13 Oct 2021
- Primary completion30 Jun 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 186 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Alejandro Mejia, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087550
- Sponsor's protocol ID
- 058.HPB.2021.D
- Status last verified
- Aug 2023
- First submitted
- 8 Oct 2021
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
- ClinicalTrials.gov ID
- NCT05087550
- Acronym / sponsor ID
- 058.HPB.2021.D
- Conditions
- Liver Transplant
- Keywords
- Organ Procurement and Transplant Network (OPTN), Liver Allocation Policy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 21 Oct 2021 (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.
Organ procurement organizations (OPO) have increased organ recovery efficiency and yield and have also reduced organ acquisition charges. The new liver allocation policy came into effect in February 2020 and aims to increase access to organs for waitlist candidates with the greatest severity of illness. The urgent change was driven by the perception that patients were dying because of arbitrary boundaries and inequitable access. Critics of the new policy have highlighted the potential cost implications particularly at an OPO level. A study of five OPOs throughout the United States highlighted an increase in costs ranging from 43% - 206% despite the same volume of livers transplanted. The main reason for the cost appears to lie in organ handling and transport. This mirrors the findings of Puri and colleagues who acknowledged changes to lung transplantation at Barnes Jewish Hospital in the pre- and post-policy eras and reported a substantial decline in local donors. The new lung system has also resulted in a higher organ discard rate and ultimately higher costs. Such data has generated meaningful discussions regarding optimizing organ allocation polices, however, data from individual transplant centers is lacking in the literature. Changes at a transplant center level relating to recipient costs are likely impacted by the new policy, which could be related to patient travel, accommodation, work up etc.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplantation patients | – | Procedure: Liver Transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from patients who underwent liver transplantation between February 4th, 2019 - February 4th, 2020, and February 5th, 2020 - February 5th, 2021 will be included in the study.
Key inclusion criteria (2 listed)
- Age 18 years or older
- Underwent liver transplantation at MDMC between February 4th 2019 - February 4th 2020 and February 5th 2020 - February 5th 2021
Key exclusion criteria (2 listed)
- Below 18 years of age
- Did not undergo liver transplantation
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 TransplantationPatients who underwent liver transplantation at Methodist Dallas Medical Center | Procedure or surgery | Liver Transplantation patients |
Primary outcome
Liver transplant volume
Time frame: 02/04/2019 - 02/05/2021
Cost
Time frame: 02/04/2019 - 02/05/2021
Costs related to: * Transplant volume and organ recovery information * Transportation costs, distance traveled, travel time * Personnel costs * Hospital charges/costs
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Alejandro Mejia, MD principal investigator
The Methodist Hospital Research Institute
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 Transplant, run by Methodist Health System at 1 site in United States.
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 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 24 Mar 2026. 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 United States. 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?
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?
Liver transplant volume (time frame: 02/04/2019 - 02/05/2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.