Safety and Feasibility of Normothermic Machine Perfusion to Rescue Orphan Livers
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/6/2018 |
| Start Date: | April 2019 |
| End Date: | December 2023 |
| Contact: | Cristiano Quintini, MD |
| Email: | quintic@ccf.org |
| Phone: | 216 445-3388 |
Pilot Study to Assess Safety and Feasibility of Normothermic Machine Perfusion to Rescue Orphan Livers
Orphan livers are organs that have been declined for clinical use by all centers due to their
marginality. The current standard of care of liver preservation before transplant is cold
storage. NMP may allow these livers to be evaluated before transplantation. NMP has already
been used in a clinical setting with promising results. The advantage to utilizing NMP is
that it would attenuate the incidence and clinical impact of classical preservation injury,
allow liver function assessment before implantation and thus improve donor pool and outcomes
for high risk ECD liver transplants performed at our center.
marginality. The current standard of care of liver preservation before transplant is cold
storage. NMP may allow these livers to be evaluated before transplantation. NMP has already
been used in a clinical setting with promising results. The advantage to utilizing NMP is
that it would attenuate the incidence and clinical impact of classical preservation injury,
allow liver function assessment before implantation and thus improve donor pool and outcomes
for high risk ECD liver transplants performed at our center.
This will be a single center prospective cohort pilot study. 15 livers that have been
declined for clinical use by all centers due to their marginality will be preserved with NMP
in 1-18 hours after cross clamp and cold flush. The liver grafts at NMP will be at
Physiological temperature and have oxygen and nutrient supply with continuous perfusion. Once
the liver grafts have been evaluated and determined to be transplantable, the transplantation
and post-transplant care will follow the standard of care. The follow-up period is 12 months
after transplantation. The primary end point will be the rate of patient survival and primary
non function (PNF) within 30 days after transplantation, while the secondary end points will
be: Early Allograft Dysfunction (EAD), 6 months patient and graft survival, peak liver
function tests in the first 7 days after transplantation, surgical outcomes (operative time,
transfusion requirement etc.), rate of post-transplant kidney failure, assessment of
histological ischemia reperfusion (liver and bile duct), rate of vascular complications, rate
of biliary complications, hospital and ICU length of stay, rejection rate, infection rate,
the ability to predict function based on "on-pump" viability markers, and the incidence of
adverse effect (AE).
declined for clinical use by all centers due to their marginality will be preserved with NMP
in 1-18 hours after cross clamp and cold flush. The liver grafts at NMP will be at
Physiological temperature and have oxygen and nutrient supply with continuous perfusion. Once
the liver grafts have been evaluated and determined to be transplantable, the transplantation
and post-transplant care will follow the standard of care. The follow-up period is 12 months
after transplantation. The primary end point will be the rate of patient survival and primary
non function (PNF) within 30 days after transplantation, while the secondary end points will
be: Early Allograft Dysfunction (EAD), 6 months patient and graft survival, peak liver
function tests in the first 7 days after transplantation, surgical outcomes (operative time,
transfusion requirement etc.), rate of post-transplant kidney failure, assessment of
histological ischemia reperfusion (liver and bile duct), rate of vascular complications, rate
of biliary complications, hospital and ICU length of stay, rejection rate, infection rate,
the ability to predict function based on "on-pump" viability markers, and the incidence of
adverse effect (AE).
Inclusion Criteria:
- Patients undergoing primary liver transplantation
- Age 18-75 years at the time of transplantation
- Willingness and ability to comply with the study procedures
- Signed Informed Consent Form
- For patients with hepatocellular carcinoma as indication for Orthoptic Liver
Transplantation (OLT), tumor must be within Milan Criteria or down-staged to Milan
Criteria.
Exclusion Criteria:
Recipient Exclusion Criteria:
- History of prior solid organ transplantation
- Patient on a respiratory and/or cardiocirculatory support at the time of transplant
- MELD score >35
- HIV positive patient
- Patient with current severe systemic infection
- Multiorgan transplant
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