St. James's University Hospital
Leeds, West Yorkshire, LS9 7 TF, United Kingdom
Completed
NCT Number: NCT02449694
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
OCS Liver
DeviceOCS Liver will be used to preserve the donor liver
Primary outcomes
-
Number of donor livers preserved by OCS in a near physiologic state.
Time frame: Within 1 day of organ retrieval
-
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
Time frame: Within 1 day of organ retrieval
Secondary outcomes
-
Number of donor livers maintained in a metabolically active and functioning state during preservation.
Time frame: Within 1 day of organ retrieval
-
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.
Time frame: Within 1 day of organ retrieval
-
Frequency of liver graft-related serious adverse events
Time frame: 30 days after transplantation
Sponsors and collaborators
Lead sponsor
TransMedics
Industry
Registry information
Official study 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
Acronym: REVIVE
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- May 20, 2015
- Registry last updated
- Apr 6, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.