Liver Transplant
Conditions
Brief summary
The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients. This will be a single-site clinical trial placing donor livers with 30-60% macrosteatosis on NMP, and then transplanting those that meet commonly accepted viability criteria. The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers, further expanding the donor organ pool.
Interventions
DEVICENormothermic machine perfusion (NMP) of steatotic liver
Steatotic liver grafts that are selected will be run on NMP to assess quality of graft and determine whether it meets criteria for transplantation
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years * Listed for liver transplantation at MGH * Calculated MELD-Na score \<= 25 * Able to consent
Exclusion criteria
* Status 1a * Cardiac or pulmonary disease * Prior liver transplant * Requiring pressors at the time of liver offer * MELD\<15 and asymptomatic from liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early allograft dysfunction | First week after transplant | Number of participants with initial poor function of liver allograft: measured by presence of 1 or more of the following: aspartate aminotransferase (AST) level higher than 2000 IU/L (to convert to microkatals per liter, multiply by 0.0167) within the first 7 postoperative days; bilirubin 10 mg/dL or higher (to convert to micromoles per liter, multiply by 17.104) on postoperative day 7; international normalized ratio (INR) of 1.6 or higher on postoperative day 7; or graft primary nonfunction within the first 7 days, defined as irreversible graft dysfunction leading to recipient death or emergency retransplant, in the absence of immunologic or surgical causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | First 30 days post-transplantation | Incidence of any additional adverse events, not including 24-hour ICU stay post-transplant, post-transplant transfusion \<=6 units pRBCs, \<=2 units FFP, \<=2 units 6-pack of platelets, as these are considered routine |
| Intraoperative inotropic support | At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion | Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft |
| Need for post-operative inotropic support | First 30 days post-transplantation | Number of participants in need of inotropic support upon admission to the ICU |
| Length of post-operative inotropic support | First 30 days post-transplantation | Length of inotropic support used after admission to the ICU, if needed |
| Need for post-operative mechanical ventilation | First 30 days post-transplantation | Number of participants in need of mechanical ventilation upon admission to ICU |
| Length of post-operative mechanical ventilation | First 30 days post-transplantation | Length of intubation after admission to ICU, if mechanical ventilation needed |
| ICU length of stay | First 30 days post-transplantation | Length of stay in ICU post-transplant |
| Renal replacement therapy requirement | First 30 days post-transplantation | Number of participants who require renal replacement therapy during the first 10 days after liver transplantation, if not on renal replacement prior to transplant |
| Peak AST and ALT | First 7 days post-transplantation | Concentration of peak AST and ALT |
| Internal Normalized Ratio (INR) | First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out | INR measurements for each participant until post-op day 7 or discharge |
| Total bilirubin | First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out | Total bilirubin measurement (mg/dl) on post-op day 7 or day of discharge |
| 30-day patient survival | First 30 days post-transplantation | 30-day patient survival (percentage) |
| Biopsy-proven rejection episodes | Assessed at 3, 6, and 12 months post-transplant | Number of participants with biopsy-proven rejection episodes |
| Re-listing for transplantation | First 30 days post-transplantation | Number of participants who require re-listing for liver transplantation within 30 days post-op |
| Additional procedures | Assessed at 3, 6, and 12 months post-transplant | Number of participants that require additional procedures beyond normal recovery standard of care post-liver transplant |
| Re-admissions | Assessed at 3, 6, and 12 months post-transplant | Number of participants with re-admissions after initial discharge |
| Ischemic cholangiopathy and anastomotic strictures by imaging | Assessed at 3, 6, and 12 months post-transplant | Number of participants with evidence of ischemic cholangiopathy and anastomotic strictures by imaging |
| Vascular complications by cross-sectional imaging or angiography | Assessed at 3, 6, and 12 months post-transplant | Number of participants with evidence of vascular complications by cross-sectional imaging or angiography |
| Presence of steatosis by imaging or histology | Assessed at 3, 6, and 12 months post-transplant | Number of participants with evidence of steatosis by imaging or histology |
| Degree of steatosis by imaging or histology | Assessed at 3, 6, and 12 months post-transplant | Degree of steatosis by imaging or histology, if present |
| Renal dysfunction | Assessed at 3, 6, and 12 months post-transplant | Presence of a decrease in GFR \> 40 from pre-transplant baseline or creatinine \>2 if received simultaneous liver-kidney transplant |
| Hyperlipidemia | Assessed at 3, 6, and 12 months post-transplant | Number of participants with evidence of hyperlipidemia |
| Immunosuppression medications | Assessed at 3, 6, and 12 months post-transplant | Types of immunosuppression medications required |
| Dosage of immunosuppression medications | Assessed at 3, 6, and 12 months post-transplant | Dosage of immunosuppression medications required in respective unit measurement (i.e. milligrams) |
| Drug levels of immunosuppression medications | Assessed at 3, 6, and 12 months post-transplant | Drug levels of immunosuppression medications present in blood titers drawn from participant in respective unit measurement (i.e. ng/mL) |
| Graft failure | Assessed at 3, 6, and 12 months post-transplant | Number of participants with evidence of graft failure |
| Patient death | Assessed at 3, 6, and 12 months post-transplant | Number of participants with evidence of patient death |
| Liver function tests more than 3 times normal | Assessed at 3, 6, and 12 months post-transplant | Number of participants with liver function tests more than 3 times normal; liver function tests (LFTs) will measure AST/ALT, bilirubin, INR |
Countries
United States
Contacts
Primary ContactHeidi Yeh, MD
Outcome results
None listed