Using discarded livers for transplantation with machine perfusion
A Prospective, Single-Center, Non-Randomized, Clinical Trial of Transplantation of Discarded Livers Using Normothermic Machine Perfusion (NMP)
This study is testing if using a special machine to keep discarded livers warm can make them good enough for transplant into patients who need a new liver.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT04483102 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility of transplanting discarded livers that have undergone normothermic machine perfusion (NMP) compared to standard cold preservation methods. Up to 71 marginal livers that were previously declined for transplantation will be treated with NMP using the OrganOx® metra device to assess their viability. Viable livers will then be transplanted into eligible patients, with outcomes monitored for up to one year post-transplantation. The results will be compared to contemporary groups receiving standard liver transplants to determine the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates for this study are patients in need of a liver transplant who meet the eligibility criteria for receiving a marginal liver.
Not a fit: Patients who are not eligible for liver transplantation or those with contraindications to receiving a marginal liver may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could increase the availability of viable livers for transplantation, potentially improving outcomes for patients with liver disease.
How similar studies have performed: Other studies have shown promise with similar approaches using machine perfusion for organ preservation, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
PRE-NMP DECLINED LIVER ELIGIBILITY: Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Will Chapman, MD — Washington University School of Medicine
- Study coordinator: Anna Rois, RN, BSN
- Email: roise@wustl.edu
- Phone: 314-362-5705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.