Brief Summary
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Brief Title
OCS Liver PROTECT Continued Access Protocol
Detailed Description
A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:
1. Donor age equal to or greater than 40 years old, or
2. Expected cross clamp time of 6 hours or greater, or
3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or
4. Steatotic lever \>0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)
A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.
All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).
1. Donor age equal to or greater than 40 years old, or
2. Expected cross clamp time of 6 hours or greater, or
3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or
4. Steatotic lever \>0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)
A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.
All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).
Completion Date
Completion Date Type
Actual
Conditions
Liver Transplant
Eligibility Criteria
Recipient Inclusion Criteria:
* Registered primary liver transplant candidate, male or female
* Age ≥ 18 years
* 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
Donor Inclusion Criteria
* Donor age ≥ 40 years, or
* Expected cross-clamp time ≥ 6 hours, or
* Donor after circulatory death (DCD) with age ≤ 55 years, or
* Steatotic liver \> 0% and ≤ 40% macrosteatosis at time of retrieval
Donor Exclusion Criteria
* Living donors
* Liver intended for split transplants
* Positive serology (HIV, Hepatitis B surface antigen \& Hepatitis C)
* Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
* Donor livers with macrosteatosis of \> 40% based on retrieval biopsy readout.
* Registered primary liver transplant candidate, male or female
* Age ≥ 18 years
* 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
Donor Inclusion Criteria
* Donor age ≥ 40 years, or
* Expected cross-clamp time ≥ 6 hours, or
* Donor after circulatory death (DCD) with age ≤ 55 years, or
* Steatotic liver \> 0% and ≤ 40% macrosteatosis at time of retrieval
Donor Exclusion Criteria
* Living donors
* Liver intended for split transplants
* Positive serology (HIV, Hepatitis B surface antigen \& Hepatitis C)
* Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
* Donor livers with macrosteatosis of \> 40% based on retrieval biopsy readout.
Inclusion Criteria
Inclusion Criteria:
* Registered primary liver transplant candidate, male or female
* Age ≥ 18 years
* Signed (1) written informed consent document and (2) authorization to use and disclose protected health information
Inclusion Criteria
* Donor age ≥ 40 years, or
* Expected cross-clamp time ≥ 6 hours, or
* Donor after circulatory death (DCD) with age ≤ 55 years, or
* Steatotic liver \> 0% and ≤ 40% macrosteatosis at time of retrieval
Donor
* Registered primary liver transplant candidate, male or female
* Age ≥ 18 years
* Signed (1) written informed consent document and (2) authorization to use and disclose protected health information
Inclusion Criteria
* Donor age ≥ 40 years, or
* Expected cross-clamp time ≥ 6 hours, or
* Donor after circulatory death (DCD) with age ≤ 55 years, or
* Steatotic liver \> 0% and ≤ 40% macrosteatosis at time of retrieval
Donor
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
NCT04186221
Org Class
Industry
Org Full Name
TransMedics
Org Study Id
OCS-LVR10202019
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.
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
Secondary Outcomes
Outcome Description
Patient survival at day 30 post transplantation.
Outcome Time Frame
30 days after transplant
Outcome Measure
Patient Survival at Day 30 After Transplant
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
Milan Kinkhabwala
Investigator Email
MKinkhab@montefiore.org
Investigator Phone