Brief Summary
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
Brief Title
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
Detailed Description
The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Liver Transplantation
Liver Preservation for Transplant
Eligibility Criteria
Inclusion Criteria:
* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
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 for \>2 weeks and/or requiring hemodialysis
* Multi-organ transplant
* Ventilator dependent
* Dependent on \> 1 IV inotrope to maintain hemodynamics
* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
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 for \>2 weeks and/or requiring hemodialysis
* Multi-organ transplant
* Ventilator dependent
* Dependent on \> 1 IV inotrope to maintain hemodynamics
Inclusion Criteria
Inclusion Criteria:
* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
* Registered male or female primary Liver transplant candidate
* Age ≥18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
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
NCT02522871
Org Class
Industry
Org Full Name
TransMedics
Org Study Id
OCS-LVR-092014
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)
Primary Outcomes
Outcome Description
Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)
Outcome Measure
Participants With Early Liver Allograft Dysfunction (EAD)
Outcome Time Frame
7 days
Outcome Description
Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.
Outcome Measure
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient
Outcome Time Frame
30 days
Secondary Outcomes
Outcome Description
Patient survival at day 30 after transplantation
Outcome Time Frame
30 days after transplant
Outcome Measure
Patient Survival at Day 30 After Transplant
Outcome Description
Patient survival at initial hospital discharge post liver transplantation
Outcome Time Frame
at initial hospital discharge post liver transplant, an average of 11 days
Outcome Measure
Patient Survival at Initial Hospital Discharge Post Liver Transplant
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
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
Milan Kinkhabwala
Investigator Email
MKinkhab@montefiore.org
Investigator Phone