Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation

Liver Preservation Clinical Trial

— REVIVE  

Official title:

Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449694
• Other study ID #: OCS-LVR-022015
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: April 4, 2018
• Start date: May 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2018
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2018
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Registered male or female primary Liver transplant candidate

• Age =18 years old

• Signed: written informed consent

Exclusion Criteria:

• Acute, fulminant liver failure;

• Prior solid organ or bone marrow transplant;

• Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl (>265 mmol/L) for >2 weeks and/or requiring hemodialysis;

• Multi-organ transplant;

• Ventilator dependent;

• Dependent on > 1 IV inotrope to maintain hemodynamics;

• Malignancy excluding HCC;

• Infection.

Related Conditions & MeSH terms

• Liver Preservation

Intervention

Device:
• OCS Liver
OCS Liver will be used to preserve the donor liver

Locations

Country	Name	City	State
United Kingdom	St. James's University Hospital	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
TransMedics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of donor livers preserved by OCS in a near physiologic state.		Within 1 day of organ retrieval
Primary	Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted		Within 1 day of organ retrieval
Secondary	Number of donor livers maintained in a metabolically active and functioning state during preservation.		Within 1 day of organ retrieval
Secondary	Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation.		Within 1 day of organ retrieval
Secondary	Frequency of liver graft-related serious adverse events		30 days after transplantation