CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
The Medtronic Portable Bypass System (PBS®)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01274520
NCT01274520N/ACompleted

Hypothermic Machine Preservation of Extended Criteria Liver Allografts for Transplantation

Columbia University·interventional·Posted Jan 11, 2011·Updated Jul 27, 2020

In Brief

A clinical study evaluating The Medtronic Portable Bypass System (PBS®) for Liver Damage. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This is a study comparing a technique of continuous circulation to the liver as a means of preventing liver damage during transportation to the transplant hospital. This new technique of Machine Perfusion (MP) will be compared to the standard technique where the liver is maintained in a bag of solution on ice without circulation. The investigators will evaluate and compare the outcomes of the transplants with the new technique to the standard technique. There will be 24 MP patient's in the study. The investigators have previously used this technique with success in 20 human liver transplant patients. The investigators think there will be a benefit in terms of less damage to and better function of the donor liver which will result in faster recovery for the patients. This protective effect may allow us to successfully transplant more patients and prevent people from dying while waiting for a liver transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Damage
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2011
Enrollment StartDec 19, 2009
Primary CompletionJul 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.5 years ago

Interventions

The Medtronic Portable Bypass System (PBS®)device

Will be used for machine perfusion of liver grafts.