Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
- Conditions
- Liver Transplant
- Interventions
- Device: Normothermic machine perfusion (NMP) of steatotic liver
- Registration Number
- NCT06088758
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age 18-80 years
- Listed for liver transplantation at MGH
- Calculated MELD-Na score <= 25
- Able to consent
- Status 1a
- Cardiac or pulmonary disease
- Prior liver transplant
- Requiring pressors at the time of liver offer
- MELD<15 and asymptomatic from liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Liver Transplantation with Steatotic Liver Normothermic machine perfusion (NMP) of steatotic liver Graft will be selected if 30-60% macrosteatosis and transplanted into liver transplant recipient with MELD of 15-25.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Patient death Assessed at 3, 6, and 12 months post-transplant Number of participants with evidence of patient death
Length of post-operative mechanical ventilation First 30 days post-transplantation Length of intubation after admission to ICU, if mechanical ventilation needed
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
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)
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
Re-admissions Assessed at 3, 6, and 12 months post-transplant Number of participants with re-admissions after initial discharge
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
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
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)
Length of post-operative inotropic support First 30 days post-transplantation Length of inotropic support used after admission to the ICU, if needed
Biopsy-proven rejection episodes Assessed at 3, 6, and 12 months post-transplant Number of participants with biopsy-proven rejection episodes
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
Need for post-operative mechanical ventilation First 30 days post-transplantation Number of participants in need of mechanical ventilation upon admission to ICU
Peak AST and ALT First 7 days post-transplantation Concentration of peak AST and ALT
Re-listing for transplantation Assessed at 3, 6, and 12 months post-transplant Number of participants who require re-listing for transplantation within 1 year post-op
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
Hyperlipidemia Assessed at 3, 6, and 12 months post-transplant Number of participants with evidence of hyperlipidemia
Graft failure Assessed at 3, 6, and 12 months post-transplant Number of participants with evidence of graft failure
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
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)
Trial Locations
- Locations (1)
Massachusetts General Brigham
🇺🇸Boston, Massachusetts, United States