Hypothermic Machine Preservation-Phase 2

NCT01274520 | Completed Results DMC FDA Device

• 1 other identifier: AAAD6236
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Damage

Keywords

ECD liver transplant allografts; Hypothermic machine perfusion; Cold storage preservation; liver transplant; portable bypass system; machine perfusion preservation; extended criteria liver

Outcome Measures

Primary Outcomes (2)

• Patient Survival at One Year Post-Transplantation

  Post-Operative Day 1 to Day 365

• Graft Survival at One Year Post-Transplantation

  Analysis was based on the amount of liver allografts in each cohort that were deemed to be clinically functional at 1 year post-transplantation (i.e. no re-transplantation required).

  Post-Operative Day 1 to Day 365

Secondary Outcomes (10)

• Incidence of Primary Graft Nonfunction

  Post-Operative Day 1 to Day 7

• Incidence of Early Allograft Dysfunction (EAD)

  Within the first 7 days post-transplantation

• Incidence of Post-Operative Complications

  1 Month Post-Transplantation

• Incidence of Bile Leaks

  Post-Operative Day 1 to Day 365

• Incidence of Re-Operation For Bleeding

  Post-Operative Day 1 to Day 365

Study Arms (2)

Experimental: Hypothermic Machine Perfusion Group

EXPERIMENTAL

The Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole and the BioCal® blood temperature control module will be used for machine perfusion of liver grafts. These products are commercially available and used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.

Device: The Medtronic Portable Bypass System (PBS®)

Matched control group

NO INTERVENTION

The proposed study is a matched cohort design. Subjects will be matched with 24 historical control patients who received similar cold stored ECD grafts. Subjects will be matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses will be performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.

Interventions

The Medtronic Portable Bypass System (PBS®) DEVICE

Will be used for machine perfusion of liver grafts.

Also known as: Medtronic Portable Bypass System (PBS®)

Experimental: Hypothermic Machine Perfusion Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• Guarrera JV, Henry SD, Samstein B, Reznik E, Musat C, Lukose TI, Ratner LE, Brown RS Jr, Kato T, Emond JC. Hypothermic machine preservation facilitates successful transplantation of "orphan" extended criteria donor livers. Am J Transplant. 2015 Jan;15(1):161-9. doi: 10.1111/ajt.12958. Epub 2014 Dec 17.

  PMID: 25521639 DERIVED

Results Point of Contact

• Title: James V. Guarrera, MD, FACS
• Organization: Columbia University College of Physicians and Surgeons - Center for Liver Disease and Transplantation

jjg46@cumc.columbia.edu

(212)305.3839

Study Officials

• James V Guarrera, MD, FACS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: January 11, 2011
• Study Start: December 19, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: July 27, 2020
• Results First Posted: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)