N/A
N=49
Hypothermic Machine Preservation-Phase 2
Liver Damage
Bottom Line
View on ClinicalTrials.gov: NCT01274520 ↗Enrolled (actual)
49
Serious AEs
34.7%
Results posted
Jul 2020
Primary outcome: Primary: Patient Survival at One Year Post-Transplantation — 19; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Medtronic Portable Bypass System (PBS®) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Survival at One Year Post-Transplantation |
19; 19 | — |
| PRIMARY Graft Survival at One Year Post-Transplantation |
23; 23 | — |
| SECONDARY Incidence of Primary Graft Nonfunction |
2; 1 | — |
| SECONDARY Incidence of Early Allograft Dysfunction (EAD) |
9; 5 | — |
| SECONDARY Incidence of Post-Operative Complications |
0; 1; 1; 1 | — |
| SECONDARY Incidence of Bile Leaks |
3; 0 | — |
| SECONDARY Incidence of Re-Operation For Bleeding |
5; 2 | — |
| SECONDARY Incidence of Hernia Events Within 1 Year Post-Transplantation |
2; 4 | — |
| SECONDARY Hospital Length of Stay (Index Transplant Hospitalization) |
16.5; 10 | — |
| SECONDARY Time With Stent (Days) |
86; 66.5 | — |
| SECONDARY Incidence of Biliary Strictures |
10; 2 | — |
| SECONDARY Incidence of Endoscopic Retrograde Cholangiopancreatographies (ERCPs) |
35; 7 | — |
Summary
This is a study comparing a technique of continuous circulation to the liver as a means of preventing liver damage during transportation to the transplant hospital. This new technique of Machine Perfusion (MP) will be compared to the standard technique where the liver is maintained in a bag of solution on ice without circulation. The investigators will evaluate and compare the outcomes of the transplants with the new technique to the standard technique. There will be 24 MP patient's in the study. The investigators have previously used this technique with success in 20 human liver transplant patients. The investigators think there will be a benefit in terms of less damage to and better function of the donor liver which will result in faster recovery for the patients. This protective effect may allow us to successfully transplant more patients and prevent people from dying while waiting for a liver transplant.
Eligibility Criteria
Inclusion Criteria
- Signed written informed IRB consent by patient or patient's legally appointed representative.
- Be at least 18 years of age; male or female.
- Listed with UNOS for liver transplantation.
- Organ declined by at least one transplant center
- Extended criteria donor as defined by:
- Presence of hepatitis C antibody
- Donation after Cardiac Death (DCD)
- Severe Hypernatremia: donor serum sodium >165 meq/L for at least 12 hours prior to procurement
- Donor age ≥65 years
- Presence of significant steatosis >25% macrovesicular by biopsy
- Evidence of significant donor ischemic injury
- Current donor serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1000 IU/L
- Ischemic injury evidenced by prolonged hypotension, high pressor requirement and/or rising serum liver function tests or one test more than five times the upper limit of normal (AST, ALT, or Total Bilirubin)
Exclusion Criteria
- Patients in whom the donor liver will be subjected to less than 4 hours of cold ischemia (surgeon desires immediate implantation)
- Patient hospitalized in intensive care unit (ICU) at time of transplantation and/or physiologic MELD score >35
- Dual organ recipient
- ABO incompatibility
- Retransplantation
Data sourced from ClinicalTrials.gov (NCT01274520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.