Health TrialsbyHealthPanel

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

ConditionLiver Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years

Listed for liver transplantation at MGH

Calculated MELD-Na score <= 25

Able to consent

Disqualifiers

Status 1a

Cardiac or pulmonary disease

Prior liver transplant

Requiring pressors at the time of liver offer

Trial design

Design model

Single group

Treatments tested in this trial

  • Normothermic machine perfusion (NMP) of steatotic liver

    Device

    Steatotic liver grafts that are selected will be run on NMP to assess quality of graft and determine whether it meets criteria for transplantation

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Liver Transplantation with Steatotic LiverExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
First week after transplant

Secondary outcomes

1

Intraoperative inotropic support

Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft

Time frame
At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion
2

Need for post-operative inotropic support

Number of participants in need of inotropic support upon admission to the ICU

Time frame
First 30 days post-transplantation
3

Length of post-operative inotropic support

Length of inotropic support used after admission to the ICU, if needed

Time frame
First 30 days post-transplantation
4

Need for post-operative mechanical ventilation

Number of participants in need of mechanical ventilation upon admission to ICU

Time frame
First 30 days post-transplantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now