Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02478151
Recruitment Status : Enrolling by invitation
First Posted : June 23, 2015
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE December 1, 2014
First Posted Date  ICMJE June 23, 2015
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE July 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
  • Rates of primary graft non-function [ Time Frame: 3 months ]
  • Rates of re-transplantation [ Time Frame: 3 months ]
  • Rates of recipient death [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2015)
  • Rate of device failures resulting in organ discard [ Time Frame: 3 months ]
  • Recruitment rates to the study [ Time Frame: 3 months ]
    Measured by the ratio of actual / eligible candidate donors recruited to the study
  • Ischemia- reperfusion injury associated with organ storage [ Time Frame: 7 days ]
    Assessed by a post-perfusion biopsy
  • Ischemia- reperfusion injury associated with organ storage [ Time Frame: 7 days ]
    Assessed by measuring the peak serum aspartate transaminase level (AST) within 7 days post-transplant
  • The function of liver grafts stored with the Metra™ device [ Time Frame: 3 months ]
    Measured by bilirubin, alkaline phosphatase, AST and INR levels at days 1-7 post-transplant. The measure is a composite.
  • The function of liver grafts stored with the Metra™ device [ Time Frame: 3 months ]
    Measured by bilirubin, alkaline phosphatase, AST and INR levels at day 30 post-transplant. The measure is a composite.
  • The function of liver grafts stored with the Metra™ device [ Time Frame: 3 months ]
    Measured by bilirubin, alkaline phosphatase, AST and INR levels at month 3 post-transplant. The measure is a composite.
  • The function of liver grafts stored with the Metra™ device [ Time Frame: 3 months ]
    Measured by Lactate at days 1-3 post-transplant. The measure is a composite.
  • The ability of perfusion parameters to predict clinical outcomes following transplantation [ Time Frame: 3 months ]
    Perfusion flows and pressures will be studied to determine their correlation with graft injury and function. The measure is a composite.
  • The ability of perfusion parameters to predict clinical outcomes following transplantation [ Time Frame: 3 months ]
    Perfusate blood gas parameters will be studied to determine their correlation with graft injury and function. The measure is a composite.
  • The ability of perfusion parameters to predict clinical outcomes following transplantation [ Time Frame: 3 months ]
    Bile production will be studied to determine their correlation with graft injury and function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
Official Title  ICMJE A Single Centre Study of the Feasibility and Safety of Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
Brief Summary This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. Participants will be followed for 3 months following transplantation and their outcomes recorded.
Detailed Description Liver transplantation is a life-saving procedure but its success has been limited by a shortage of suitable donor organs. Much emphasis is now placed on optimising the condition of those organs that are available, to enable more higher risk organs to be transplanted safely. An effective means of pre-transplant viability assessment would not only allow greater use of higher risk donors but also minimise the risk of primary non-function by identifying and excluding non-viable organs before subjecting a patient to the risk of surgery. Organ storage under normothermic perfusion conditions enables organ function to be evaluated prior to transplantation and further has been shown to prevent organ injury which is sustained during standard cold storage. This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. This study will evaluate liver function post-transplantation using standard clinical parameters. Participants will be followed for 3 months following transplantation and their outcomes recorded. Participants will undergo no other study procedures. Feasibility will be measured using the ratio of actual / eligible candidate donors recruited to the study and will also encompass logistical issues with respect to transportation, and ease of use. Safety will be assessed by rates of device failures resulting in organ discard, primary graft non-function, re-transplantation, and recipient death.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE End-stage Liver Disease
Intervention  ICMJE Device: OrganOx Metra
Normothermic machine perfusion (NMP) Metra device
Study Arms  ICMJE Experimental: OrganOx Metra
OrganOx Metra Device
Intervention: Device: OrganOx Metra
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 5, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2015)
10
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients (18 years or more)
  • Active on the waiting list for liver transplantation
  • Able to give informed consent

Exclusion Criteria:

  • Age less than 18 years
  • Acute/fulminant liver failure
  • Transplantation of more than one organ (e.g. liver and kidney)
  • Refusal of informed consent
  • Unable to give informed consent
  • Re-transplantation Diagnosis of Hepatopulmonary Syndrome
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02478151
Other Study ID Numbers  ICMJE 14-8132-B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David R Grant, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP