Brief Summary
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
Brief Title
OCS Liver DCD Trial
Detailed Description
To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.
Completion Date
Completion Date Type
Actual
Conditions
Liver Transplant
Eligibility Criteria
Inclusion Criteria:
* Registered primary liver transplant candidate
* Age ≥ 18 years
* Obtained informed consent
Exclusion Criteria:
* Acute, fulminant liver failure
* Prior solid organ or bone marrow transplant
* Ventilator dependent on day of transplant/donor organ offer
* Registered primary liver transplant candidate
* Age ≥ 18 years
* Obtained informed consent
Exclusion Criteria:
* Acute, fulminant liver failure
* Prior solid organ or bone marrow transplant
* Ventilator dependent on day of transplant/donor organ offer
Inclusion Criteria
Inclusion Criteria:
* Registered primary liver transplant candidate
* Age ≥ 18 years
* Obtained informed consent
* Registered primary liver transplant candidate
* Age ≥ 18 years
* Obtained informed consent
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04194437
Org Class
Industry
Org Full Name
TransMedics
Org Study Id
OCS-LVR-092019
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation
Primary Outcomes
Outcome Description
Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation
Outcome Measure
Liver Graft Survival Through 6 Months Post-transplant
Outcome Time Frame
6 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Juan Rocca
Investigator Email
jrocca@montefiore.org
Investigator Phone