Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-26 @ 5:01 AM
Study NCT ID:
NCT05087550
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
Sponsor:
Methodist Health System
Organization:
Study Overview
Official Title:
Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: