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Safety and Feasibility of Normothermic Machine Perfusion to Rescue Orphan Livers

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ClinicalTrials.gov Identifier: NCT03456284
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Cristiano Quintini, The Cleveland Clinic

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, reduce EAD and other complications, allow liver function assessment before implantation and thus improve outcomes for high risk ECD liver transplants performed at our center.

Condition or disease Intervention/treatment Phase
Liver Transplantation Device: Normothermic Liver perfusion Not Applicable

Detailed Description:
This will be a single center prospective cohort pilot study. 19 livers that have been declined for clinical use by all centers due to their marginality will be preserved with NMP in 2-18 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 post-transplant Early Allograft Dysfunction (EAD), while the secondary end points will be: primary non function (PNF) rate, 1 and 6 months patient and graft survival, peak liver function tests in the first 7 days after transplantation, intraoperative hepatic arterial and portal flow measurement, rate and magnitude of post-reperfusion syndrome, 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). The outcome will be compared to a control group of 38 historical patients (matched with a 1:2 ratio) transplanted in our program in the past 10 years (liver preserved using CS). Control subjects will be matched using donor and recipient age, Model for End-Stage Liver Disease (MELD) score, cold ischemia time, donor risk index and presence of steatosis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Assess Safety and Feasibility of Normothermic Machine Perfusion to Rescue Orphan Livers
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normothermic Liver perfusion
This group has the liver grafts preserved using the Normothermic Liver perfusion Device
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. peak aspartate aminotransferase (AST) in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST

  4. peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST

  5. peak bilirubin in the first 7 days post-transplantation [ Time Frame: in the first 7 days post-transplantation ]
    CLINICAL LABORATORY TEST



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456284


Contacts
Contact: Cristiano Quintini, MD 216 445-3388 quintic@ccf.org
Contact: Kevin Smith 2164445868 smithk24@ccf.org

Locations
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Cristiano Quintini, MD    216-445-3388    quintic@ccf.org   
Contact: Kevin Smith    2164445868    smithk24@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Cristiano Quintini, MD The Cleveland Clinic

Responsible Party: Cristiano Quintini, Director of Liver transplantation, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03456284     History of Changes
Other Study ID Numbers: Orphan liver
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Liver Extracts
Hematinics