Status:
ACTIVE_NOT_RECRUITING
RESTORE Declined Livers Study
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Mid-America Transplant
OrganOx Ltd.
Conditions:
Liver Diseases
Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants...
Detailed Description
This is a single center, prospective, non-randomized, clinical trial to assess the feasibility of successful transplantation of NMP-treated livers to patients. First, up to 71 marginal livers declined...
Eligibility Criteria
Inclusion
- PRE-NMP DECLINED LIVER ELIGIBILITY:
- DCD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) in DCD donors less than 40 minutes
- DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) less than 15 minutes
- DBD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with less than 8 hours cold ischemia time and DCD livers with less than 7 hours cold ischemia time (defined as the interim from initiation of donor in vivo cold organ preservation to removal of the liver graft from cold storage)
- 'Rapid Recovery' donors for liver procurement, meeting the above criteria
- Suboptimal in situ flush
Exclusion
- DBD or DCD donor less than 6 years old
- DCD grafts with donor functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) greater than or equal to 40 minutes
- DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) greater than or equal to 15 minutes
- DBD livers with cold ischemia time greater than or equal to 8 hours and DCD livers with greater than or equal to 7 hours cold ischemia time
- Donor serum bilirubin greater than or equal to 5 mg/dL
- Liver weight less than 1 kg or greater than or equal to 3.5 kg
- Grafts from patients with HIV infection
- Cirrhotic livers
- Livers with bridging fibrosis
- LIVER TRANSPLANTATION - HUMAN
- Inclusion criteria:
- Subject must be greater than or equal to 18 years of age.
- Subject with end-stage liver disease who is actively listed for primary liver transplantation on the UNOS waiting list
- Subject, or a legally authorized representative, has given informed consent to participate in the study
- Subject has a frailty classification of "Mild frailty/No frailty (Robust)", based on the Liver Frailty Index (LFI), which has been assessed within 6 months prior to liver transplant OR Subject is able to perform \>350 m on a 6 minute walk test (6MWT) within 6 months prior to liver transplant.
- In all cases, the "most recent" (and within 6 months prior to transplant) measurement of LFI or 6MWT will be used to determine eligibility.
- Exclusion criteria:
- Subject is currently listed as a UNOS status 1A.
- Subject is requiring oxygen therapy via ventilator/respiratory support.
- Subject is planned to undergo simultaneous solid organ transplant.
- Subject is pregnant at the time of transplant.
- Subject MELD score 29 or higher
- Subject receives re-transplantation of liver.
Key Trial Info
Start Date :
December 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04483102
Start Date
December 3 2020
End Date
December 31 2025
Last Update
June 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110