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

Liver Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087550
• Other study ID #: 058.HPB.2021.D
• Status: Completed
• Start date: October 13, 2021
• Est. completion date: August 9, 2023

Study information

• Verified date: August 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: August 9, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Procedure:
• Liver Transplantation
Patients who underwent liver transplantation at Methodist Dallas Medical Center

Locations

Country	Name	City	State
United States	The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Methodist Health System	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver transplant volume		02/04/2019 - 02/05/2021
Primary	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