Brief Summary
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
Brief Title
Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
Detailed Description
Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Liver Transplantation
Eligibility Criteria
Inclusion Criteria:
* ≥18 years of age
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* De novo liver transplant recipient
* Written informed consent required
Exclusion Criteria:
* Subject is a multi-organ transplant recipient
* Subject is antibodies blood group (ABO) liver incompatible
* Subject has severe systemic infection
* Subject is Human Immunodeficiency Virus (HIV) positive
* Subject has acute/fulminant liver failure
* Subject is pregnant
* ≥18 years of age
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* De novo liver transplant recipient
* Written informed consent required
Exclusion Criteria:
* Subject is a multi-organ transplant recipient
* Subject is antibodies blood group (ABO) liver incompatible
* Subject has severe systemic infection
* Subject is Human Immunodeficiency Virus (HIV) positive
* Subject has acute/fulminant liver failure
* Subject is pregnant
Inclusion Criteria
Inclusion Criteria:
* ≥18 years of age
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* De novo liver transplant recipient
* Written informed consent required
* ≥18 years of age
* Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
* De novo liver transplant recipient
* Written informed consent required
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
NCT03484455
Org Class
Industry
Org Full Name
Organ Recovery Systems, Inc.
Org Study Id
2017-US-01-ORS
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective Randomized Multi-Center Study of the Use of the Organ Recovery Systems LifePort® Liver Transporter (LLT) System With Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplants (Perfusion to Improve Liver Outcomes in Transplantation)
Primary Outcomes
Outcome Description
EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) \>2000IU/L or Alanine Aminotransferase (ALT) \> 2000 IU/L
Outcome Measure
Number of patients in each arm with Early Allograft Dysfunction (EAD)
Outcome Time Frame
7 days
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