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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03456284
• Other study ID #: Orphan liver
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patient survival		30 days post-transplantation
Primary	The rate of primary non-function	primary non-function is defined as non life sustaining liver function requiring retransplantation or leading to death with 30 days after transplantation	30 days post-transplantation
Secondary	The rate of Early Allograft Dysfunction post-transplantation	The presence of at least one of the following at post-transplant 7 days: serum bilirubin >= 10 mg/dL, international normalized ratio (INF) >= 1.6; and/or aspartate aminotransferase (AST) > 2000 U/L at any time in the first 7 posttransplant days (POD)	7 days post-transplantation
Secondary	graft survival	The allograft will be considered lost if a patient has a liver re-transplant or in the event of patient death.	6 months post-transplantation
Secondary	peak aspartate aminotransferase (AST) in the first 7 days post-transplantation	CLINICAL LABORATORY TEST	in the first 7 days post-transplantation
Secondary	peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation	CLINICAL LABORATORY TEST	in the first 7 days post-transplantation
Secondary	peak bilirubin in the first 7 days post-transplantation	CLINICAL LABORATORY TEST	in the first 7 days post-transplantation