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Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers

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: NCT03456284
Recruitment Status : Active, not recruiting
First Posted : March 7, 2018
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Cristiano Quintini, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE February 15, 2018
First Posted Date  ICMJE March 7, 2018
Last Update Posted Date September 22, 2022
Actual Study Start Date  ICMJE March 12, 2020
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2018)
  • The rate of patient survival [ Time Frame: 30 days post-transplantation ]
  • The rate of primary non-function [ Time Frame: 30 days post-transplantation ]
    primary non-function is defined as non life sustaining liver function requiring retransplantation or leading to death with 30 days after transplantation
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
The rate of Early Allograft Dysfunction post-transplantation in Normothermically Machine Perfused (NMP) livers . [ Time Frame: 7 days post-transplantation ]
The presence of at least one of the following at post-transplant 7 days: serum bilirubin >= 10 mg/dL, international normalized ratio (INF) >= 1.6; and/or aspartate aminotransferase (AST) > 2000 U/L at any time in the first 7 posttransplant days (POD)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2018)
  • The rate of Early Allograft Dysfunction post-transplantation [ Time Frame: 7 days post-transplantation ]
    The presence of at least one of the following at post-transplant 7 days: serum bilirubin >= 10 mg/dL, international normalized ratio (INF) >= 1.6; and/or aspartate aminotransferase (AST) > 2000 U/L at any time in the first 7 posttransplant days (POD)
  • graft survival [ Time Frame: 6 months post-transplantation ]
    The allograft will be considered lost if a patient has a liver re-transplant or in the event of patient death.
  • peak aspartate aminotransferase (AST) in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST
  • peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST
  • peak bilirubin in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • primary non-function rate [ Time Frame: in the first 10 days post-transplantation ]
    primary non-function is defined as non life sustaining liver function requiring retransplantation or leading to death with 10 days after transplantation
  • graft survival [ Time Frame: 6 months post-transplantation ]
    The allograft will be considered lost if a patient has a liver re-transplant or in the event of patient death.
  • peak aspartate aminotransferase (AST) in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST
  • peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST
  • peak bilirubin in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
Official Title  ICMJE Pilot Study to Assess Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
Brief Summary Orphan livers are organs that have been declined for clinical use by all centers due to their marginality. The current standard of care of liver preservation before transplant is cold storage. NMP may allow these livers to be evaluated before transplantation. NMP has already been used in a clinical setting with promising results. The advantage to utilizing NMP is that it would attenuate the incidence and clinical impact of classical preservation injury, allow liver function assessment before implantation and thus improve donor pool and outcomes for high risk ECD liver transplants performed at our center.
Detailed Description This will be a single center prospective cohort pilot study. 30 livers that have been declined for clinical use by all centers due to their marginality will be preserved with NMP in 1-18 hours after cross clamp and cold flush. The liver grafts at NMP will be at Physiological temperature and have oxygen and nutrient supply with continuous perfusion. Once the liver grafts have been evaluated and determined to be transplantable, the transplantation and post-transplant care will follow the standard of care. The follow-up period is 12 months after transplantation. The primary end point will be the rate of patient survival and primary non function (PNF) within 30 days after transplantation, while the secondary end points will be: Early Allograft Dysfunction (EAD), 6 months patient and graft survival, peak liver function tests in the first 7 days after transplantation, surgical outcomes (operative time, transfusion requirement etc.), rate of post-transplant kidney failure, assessment of histological ischemia reperfusion (liver and bile duct), rate of vascular complications, rate of biliary complications, hospital and ICU length of stay, rejection rate, infection rate, the ability to predict function based on "on-pump" viability markers, and the incidence of adverse effect (AE).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Transplantation
Intervention  ICMJE Device: Normothermic Liver perfusion
The liver grafts will be preserved and evaluated at physiological temperature and have continuous perfusion with oxygen and nutrient supply in the ex vivo organ preservation phase
Study Arms  ICMJE Experimental: Normothermic Liver perfusion
This group has the liver grafts preserved using the Normothermic Liver perfusion Device
Intervention: Device: Normothermic Liver perfusion
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2021)
30
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2018)
19
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing primary liver transplantation
  • Age 18-75 years at the time of transplantation
  • Willingness and ability to comply with the study procedures
  • Signed Informed Consent Form
  • For patients with hepatocellular carcinoma as indication for Orthoptic Liver Transplantation (OLT), tumor must be within Milan Criteria or down-staged to Milan Criteria.

Exclusion Criteria:

Recipient Exclusion Criteria:

  • History of prior solid organ transplantation
  • Patient on a respiratory and/or cardiocirculatory support at the time of transplant
  • MELD score >35
  • HIV positive patient
  • Patient with current severe systemic infection
  • Multiorgan transplant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03456284
Other Study ID Numbers  ICMJE Orphan liver
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cristiano Quintini, The Cleveland Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Cleveland Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cristiano Quintini, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date September 2022

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