NCT03456284

Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers

Pilot Study to Assess Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This will be a single center prospective cohort pilot study. 30 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).

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DEVICE	Normothermic Liver perfusion	The liver grafts will be preserved and evaluated at physiological temperature and have continuous perfusion with oxygen and nutrient supply in the ex vivo organ preservation phase

Timeline

• Start date: 2020-03-12
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2018-03-07
• Last updated: 2023-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study