Hypothermic Machine Preservation-Phase 2

Completed · Not applicable

Conditions studied: Liver Damage

In brief

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.

Key facts

Study ID

NCT01274520

Run by

Columbia University

People needed

24

Starts

2009-12-19

Expected to finish

2014-07-01

Last updated by the study team

2020-07-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed IRB consent by patient or patient's legally appointed representative.
• Be at least 18 years of age; male or female.
• Listed with UNOS for liver transplantation.
• Organ declined by at least one transplant center
• Extended criteria donor as defined by:
• Presence of hepatitis C antibody
• Donation after Cardiac Death (DCD)
• Severe Hypernatremia: donor serum sodium >165 meq/L for at least 12 hours prior to procurement
• Donor age ≥65 years
• Presence of significant steatosis >25% macrovesicular by biopsy
• Evidence of significant donor ischemic injury
• Current donor serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1000 IU/L
• Ischemic injury evidenced by prolonged hypotension, high pressor requirement and/or rising serum liver function tests or one test more than five times the upper limit of normal (AST, ALT, or Total Bilirubin)

You may not qualify if…

• Patients in whom the donor liver will be subjected to less than 4 hours of cold ischemia (surgeon desires immediate implantation)
• Patient hospitalized in intensive care unit (ICU) at time of transplantation and/or physiologic MELD score >35
• Dual organ recipient
• ABO incompatibility
• Retransplantation

Where it is running

• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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