Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation

NCT05087550 | Completed

• 1 other identifier: 058.HPB.2021.D
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Organ Procurement and Transplant Network (OPTN); Liver Allocation Policy

Outcome Measures

Primary Outcomes (2)

• Liver transplant volume

  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

  02/04/2019 - 02/05/2021

Study Arms (1)

Liver Transplantation patients

Procedure: Liver Transplantation

Interventions

Liver Transplantation PROCEDURE

Patients who underwent liver transplantation at Methodist Dallas Medical Center

Liver Transplantation patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Age 18 years or older
• Underwent liver transplantation at MDMC between February 4th 2019 - February 4th 2020 and February 5th 2020 - February 5th 2021

You may not qualify if:

• Below 18 years of age
• Did not undergo liver transplantation

Sponsors & Collaborators

• Washington University School of Medicine: collaborator
• Methodist Health System: lead

Study Sites (1)

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Alejandro Mejia, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: October 13, 2021
• Primary Completion: June 30, 2023
• Study Completion: August 9, 2023
• Last Updated: March 24, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)