Recruitment

Recruitment Status
Withdrawn

Inclusion Criterias

Accepted as a liver transplant candidate at the University of Pittsburgh Medical Center
Be receiving a cadaver donor liver transplant
Treated in accordance with the standard of care protocol(s) in effect for liver transplant recipients at the University of Pittsburgh Medical Center.
Accepted as a liver transplant candidate at the University of Pittsburgh Medical Center
Be receiving a cadaver donor liver transplant
Treated in accordance with the standard of care protocol(s) in effect for liver transplant recipients at the University of Pittsburgh Medical Center.

Exclusion Criterias

Prior organ transplant or cell infusion
Receiving a living done liver transplant
Undergoing multi-organ transplant
...
Prior organ transplant or cell infusion
Receiving a living done liver transplant
Undergoing multi-organ transplant
Receiving a donor liver with macrosteatosis greater than 30%
Receiving any investigation drug with the except of alemtuzamab (Camphath)
Receiving a donor liver with a cold ischemia time less that 6 hours
Pregnant or nursing female
Failed liver transplant in previous 180 days

Summary

Conditions
Liver Transplant
Type
Interventional
Phase
Phase 2 & Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

In vitro and in vivo research has consistently demonstrated an array of potential beneficial effects of prostanoids under both immune and non-immune circumstances relevant to liver allografts. (1-3) Recent reviews summarize the pharmacologic rationale and nonclinical and clinical experience supporti...

In vitro and in vivo research has consistently demonstrated an array of potential beneficial effects of prostanoids under both immune and non-immune circumstances relevant to liver allografts. (1-3) Recent reviews summarize the pharmacologic rationale and nonclinical and clinical experience supporting for the use of prostanoids, including prostacyclin and its analogs, in reducing early morbidity and mortality associated with liver transplantation. Prostaglandin-class drugs, including prostacyclin and its analogs, could represent an important advance toward the goal of reducing transplant related morbidity, mortality and associated costs by providing these benefits. Additionally, the reduction in serum creatinine and reduced need for post-operative dialysis observed in some studies has implications in protecting the kidneys from the nephrotoxic affects of the immunosuppressant agents, especially during the early post-operative period. As a chemically stable analog of prostacyclin (PGI2), peri-operative intravenous administration of Remodulin is hypothesized to ameliorate or prevent reperfusion damage and thereby decrease hospitalization time and improve the clinical outcome of liver transplantation, compared to placebo control. Remodulin, as a prostanoid, is expected to facilitate restoration of the blood supply to the revascularized graft, and to provide the well-characterized protective effects of this class of compounds in liver transplant patients.

Inclusion Criterias

Accepted as a liver transplant candidate at the University of Pittsburgh Medical Center
Be receiving a cadaver donor liver transplant
Treated in accordance with the standard of care protocol(s) in effect for liver transplant recipients at the University of Pittsburgh Medical Center.
Accepted as a liver transplant candidate at the University of Pittsburgh Medical Center
Be receiving a cadaver donor liver transplant
Treated in accordance with the standard of care protocol(s) in effect for liver transplant recipients at the University of Pittsburgh Medical Center.

Exclusion Criterias

Prior organ transplant or cell infusion
Receiving a living done liver transplant
Undergoing multi-organ transplant
...
Prior organ transplant or cell infusion
Receiving a living done liver transplant
Undergoing multi-organ transplant
Receiving a donor liver with macrosteatosis greater than 30%
Receiving any investigation drug with the except of alemtuzamab (Camphath)
Receiving a donor liver with a cold ischemia time less that 6 hours
Pregnant or nursing female
Failed liver transplant in previous 180 days

Locations

Pittsburgh, Pennsylvania, 15213
Pittsburgh, Pennsylvania, 15213

Tracking Information

NCT #
NCT01884038
Collaborators
University of Pittsburgh
Investigators
  • Principal Investigator: Amadeo Marcos, MD University of Pittsburgh Medical Center Principal Investigator: Raman Venkataramanan, Ph.D, F.C.P. University of Pittsburgh Medcial Center
  • Amadeo Marcos, MD University of Pittsburgh Medical Center Principal Investigator: Raman Venkataramanan, Ph.D, F.C.P. University of Pittsburgh Medcial Center