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Liver DamageHMP2NCT01274520

Hypothermic Machine Preservation-Phase 2

A study testing The Medtronic Portable Bypass System (PBS®) in people with Liver Damage, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Liver Damage
What is being tested?
The Medtronic Portable Bypass System (PBS®)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
19 Dec 2009to Jul 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University

    New York, New York, 10032

Other trials in United States

About this study

Official title: Hypothermic Machine Preservation of Extended Criteria Liver Allografts for Transplantation

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.

Read the detailed description

It is our hypothesis that liver machine perfusion will increase the safe utilization of the existing supply of extended criteria donor (ECD) livers by (1) increasing the quality and duration of preservation thereby reducing the clinical effects reperfusion injury (2) improving early outcomes in patients receiving ECD liver allografts (3) developing reliable markers for pretransplant assessment of the potential graft (4) giving surgeons more confidence when transplanting ECD livers and (5) allowing an avenue for ex vivo manipulation of the liver to protect or restore a transiently injured liver.

The proposed study is a matched cohort design. Potential subjects will be recruited from the Center for Liver Disease and Transplantation (CLDT) active Liver Transplant Waiting List. The Principal Investigator as well as the CoInvestigators, are all actively involved in the pre transplant evaluation process. Patients who are on the Waiting List and have provided written consent to receive an ECD graft will be recruited for this trial. 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, Model End-Stage Liver Disease (MELD) score and disease etiology.

Subjects will be noncritically ill, not in an intensive care unit, and have a MELD < 35 in order to minimize the variability in outcome in the sickest patients. All subjects must provide written informed consent and meet the inclusion and exclusion criteria.

Subjects will be followed for one year post transplantation, in conjunction with their routine liver transplant followup appointments. Retention of subjects for this trial will not be a challenge, in that the followup visit time points (postoperative days 1 through the discharge date, 7, 14, 30, 90, 180 and 365) are all consistent with our standard of care.

Conditions
Liver Damage
Being tested
The Medtronic Portable Bypass System (PBS®)
Keywords
ECD liver transplant allografts, Hypothermic machine perfusion, Cold storage preservation, liver transplant, portable bypass system, machine perfusion preservation, extended criteria liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Medtronic Portable Bypass System (PBS®)Device

    Also called Medtronic Portable Bypass System (PBS®)

    Will be used for machine perfusion of liver grafts.

Study groups in NCT01274520
Study groupRoleWhat they receive
Experimental: Hypothermic Machine Perfusion GroupExperimentalThe 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.
Receives: Device: The Medtronic Portable Bypass System (PBS®)
Matched control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Survival at One Year Post-Transplantation

    Measured: Post-Operative Day 1 to Day 365

  2. 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).

    Measured: Post-Operative Day 1 to Day 365

Secondary outcomes (10)

  1. Incidence of Primary Graft Nonfunction

    Incidence of Primary Graft Nonfunction (PNF), defined as follows:

    • Relisted for orthotopic liver transplantation (OLT) within 7 days of OLT, not for vascular thromboses
    • Alanine aminotransferase (ALT) >2000 and one or both of: acidosis with pH <7.3 or lactate >2X (two times) normal
    • International normalized ratio (INR) >2.5

    Measured: Post-Operative Day 1 to Day 7

  2. Incidence of Early Allograft Dysfunction (EAD)

    Incidence of Early Allograft Dysfunction (EAD), defined as follows:

    • Bilirubin >10 on post-operative day (POD)#7
    • International normalized ratio (INR) >1.6 on POD#7
    • Transaminase level (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) >2000 within the first 7 days

    Measured: Within the first 7 days post-transplantation

  3. Incidence of Post-Operative Complications

    Incidence of Retransplants or Hepatic Artery Thrombosis (HAT) within 1 month post-transplantation

    Measured: 1 Month Post-Transplantation

  4. Incidence of Bile Leaks

    Incidence of bile leaks.

    Measured: Post-Operative Day 1 to Day 365

  5. Incidence of Re-Operation For Bleeding

    Incidence of patients who required re-operation for a bleeding event

    Measured: Post-Operative Day 1 to Day 365

  6. Incidence of Hernia Events Within 1 Year Post-Transplantation

    Measured: Post-Operative Day 1 to Day 365

  7. Hospital Length of Stay (Index Transplant Hospitalization)

    Length of transplant hospital stay post-transplantation (Index Transplant Hospitalization)

    Measured: First admission after transplant

  8. Time With Stent (Days)

    Measure of biliary complications as evidenced by mean time with stent (in days).

    Measured: Post-Operative Day 1 to Day 365

  9. Incidence of Biliary Strictures

    Incidence of biliary strictures.

    Measured: Post-Operative Day 1 to Day 365

  10. Incidence of Endoscopic Retrograde Cholangiopancreatographies (ERCPs)

    Incidence of endoscopic retrograde cholangiopancreatographies (ERCPs)

    Measured: Post-Operative Day 1 to Day 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2011 (estimated)
  2. Study start19 Dec 2009
  3. Primary completionJul 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01274520
Sponsor's protocol ID
AAAD6236
Acronym
HMP2
Status last verified
Jul 2020
First submitted
3 Nov 2010
Last updated
27 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 25521639

Questions about this trial

What is this clinical trial studying?

A study testing The Medtronic Portable Bypass System (PBS®) in people with Liver Damage, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Survival at One Year Post-Transplantation (time frame: Post-Operative Day 1 to Day 365). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01274520, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.

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