Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool

Liver Transplant Clinical Trial

Official title:

Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088758
• Other study ID #: 2023P002561
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2026

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Heidi Yeh, MD
• Phone: 617-643-4533
• Email: hyeh[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Device:
• Normothermic 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early allograft dysfunction	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	First week after transplant
Secondary	Intraoperative inotropic support	Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft	At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion
Secondary	Need for post-operative inotropic support	Number of participants in need of inotropic support upon admission to the ICU	First 30 days post-transplantation
Secondary	Length of post-operative inotropic support	Length of inotropic support used after admission to the ICU, if needed	First 30 days post-transplantation
Secondary	Need for post-operative mechanical ventilation	Number of participants in need of mechanical ventilation upon admission to ICU	First 30 days post-transplantation
Secondary	Length of post-operative mechanical ventilation	Length of intubation after admission to ICU, if mechanical ventilation needed	First 30 days post-transplantation
Secondary	ICU length of stay	Length of stay in ICU post-transplant	First 30 days post-transplantation
Secondary	Renal replacement therapy requirement	Number of participants who require renal replacement therapy during the first 10 days after liver transplantation, if not on renal replacement prior to transplant	First 30 days post-transplantation
Secondary	Peak AST and ALT	Concentration of peak AST and ALT	First 7 days post-transplantation
Secondary	Internal Normalized Ratio (INR)	INR measurements for each participant until post-op day 7 or discharge	First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
Secondary	Total bilirubin	Total bilirubin measurement (mg/dl) on post-op day 7 or day of discharge	First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out
Secondary	30-day patient survival	30-day patient survival (percentage)	First 30 days post-transplantation
Secondary	Re-listing for transplantation	Number of participants who require re-listing for liver transplantation within 30 days post-op	First 30 days post-transplantation
Secondary	Adverse events	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	First 30 days post-transplantation
Secondary	Biopsy-proven rejection episodes	Number of participants with biopsy-proven rejection episodes	Assessed at 3, 6, and 12 months post-transplant
Secondary	Liver function tests more than 3 times normal	Number of participants with liver function tests more than 3 times normal; liver function tests (LFTs) will measure AST/ALT, bilirubin, INR	Assessed at 3, 6, and 12 months post-transplant
Secondary	Additional procedures	Number of participants that require additional procedures beyond normal recovery standard of care post-liver transplant	Assessed at 3, 6, and 12 months post-transplant
Secondary	Re-admissions	Number of participants with re-admissions after initial discharge	Assessed at 3, 6, and 12 months post-transplant
Secondary	Ischemic cholangiopathy and anastomotic strictures by imaging	Number of participants with evidence of ischemic cholangiopathy and anastomotic strictures by imaging	Assessed at 3, 6, and 12 months post-transplant
Secondary	Vascular complications by cross-sectional imaging or angiography	Number of participants with evidence of vascular complications by cross-sectional imaging or angiography	Assessed at 3, 6, and 12 months post-transplant
Secondary	Presence of steatosis by imaging or histology	Number of participants with evidence of steatosis by imaging or histology	Assessed at 3, 6, and 12 months post-transplant
Secondary	Degree of steatosis by imaging or histology	Degree of steatosis by imaging or histology, if present	Assessed at 3, 6, and 12 months post-transplant
Secondary	Renal dysfunction	Presence of a decrease in GFR > 40 from pre-transplant baseline or creatinine >2 if received simultaneous liver-kidney transplant	Assessed at 3, 6, and 12 months post-transplant
Secondary	Hyperlipidemia	Number of participants with evidence of hyperlipidemia	Assessed at 3, 6, and 12 months post-transplant
Secondary	Immunosuppression medications	Types of immunosuppression medications required	Assessed at 3, 6, and 12 months post-transplant
Secondary	Dosage of immunosuppression medications	Dosage of immunosuppression medications required in respective unit measurement (i.e. milligrams)	Assessed at 3, 6, and 12 months post-transplant
Secondary	Drug levels of immunosuppression medications	Drug levels of immunosuppression medications present in blood titers drawn from participant in respective unit measurement (i.e. ng/mL)	Assessed at 3, 6, and 12 months post-transplant
Secondary	Re-listing for transplantation	Number of participants who require re-listing for transplantation within 1 year post-op	Assessed at 3, 6, and 12 months post-transplant
Secondary	Graft failure	Number of participants with evidence of graft failure	Assessed at 3, 6, and 12 months post-transplant
Secondary	Patient death	Number of participants with evidence of patient death	Assessed at 3, 6, and 12 months post-transplant