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OCS Liver PROTECT Continued Access Protocol

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: NCT04186221
Recruitment Status : Active, not recruiting
First Posted : December 4, 2019
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
TransMedics

Tracking Information
First Submitted Date  ICMJE November 26, 2019
First Posted Date  ICMJE December 4, 2019
Last Update Posted Date September 13, 2022
Actual Study Start Date  ICMJE February 3, 2020
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
Incidence of EAD or primary non-function [ Time Frame: 7 days ]
Incidence of early allograft dysfunction or primary non-function of donor liver
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • OCS donor liver assessment during perfusion [ Time Frame: During OCS perfusion, on average 4 hours ]
    Collection of liver perfusion parameters while on OCS device
  • Patient Survival at Day 30 post-transplantation [ Time Frame: 30 days ]
    Survival
  • Patient Survival at initial hospital discharge post liver transplantation [ Time Frame: 30 days ]
    Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 2, 2019)
  • Length of initial post-transplant ICU stay [ Time Frame: ICU days, on average 5 days ]
    ICU stay
  • Length of initial post-transplant hospital stay [ Time Frame: Hospital days, on average 10 days ]
    Hospital stay
  • Evidence of ischemic biliary complications diagnosed at 6 and 12 months post transplant [ Time Frame: 6 and 12 months ]
    Ischemic biliary complications
  • Extend to reperfusion syndrome as assessed based on the rate of decrease of lactate [ Time Frame: anhepatic phase, 30-40 minutes after hepatic artery and portal vein reperfusion, 90-120 minutes after reperfusion of the transplanted liver ]
    Reperfusion syndrome
  • Pathology sample score for liver samples [ Time Frame: Procedure (Pre-retrieval, Post-OCS preservation (on average, 4 hours), post reperfusion 90-120 min after reperfusion and prior to abdominal closure) ]
    Pathology sample scoring
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE OCS Liver PROTECT Continued Access Protocol
Official Title  ICMJE Continued Access Protocol To Evaluate the Effectiveness of the Portable Organ Care System (OCS) Liver for Preserving and Assessing Donor Livers for Transplantation.
Brief Summary Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Detailed Description

A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:

  1. Donor age equal to or greater than 40 years old, or
  2. Expected cross clamp time of 6 hours or greater, or
  3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or
  4. Steatotic lever >0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)

A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.

All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, single-arm, continued access protocol
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Transplant
Intervention  ICMJE Device: OCS Liver System
OCS Liver System for preserving and assessing donor livers for transplantation
Study Arms  ICMJE Experimental: Treatment arm
Intervention: Device: OCS Liver System
Publications * Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.

*   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
Actual Enrollment  ICMJE
 (submitted: November 1, 2021)
74
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
184
Estimated Study Completion Date  ICMJE February 26, 2023
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Recipient Inclusion Criteria:

  • Registered primary liver transplant candidate, male or female
  • Age ≥ 18 years
  • Signed (1) written informed consent document and (2) authorization to use and disclose protected health information

Exclusion Criteria:

  • Acute, fulminant liver failure
  • Prior solid organ or bone marrow transplant
  • Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of > 3 mg/dl for > 2 weeks and/or requiring hemodialysis
  • Multi-organ transplant
  • Ventilator dependent
  • Dependent on > 1 IV inotrope to maintain hemodynamics

Donor Inclusion Criteria

  • Donor age ≥ 40 years, or
  • Expected cross-clamp time ≥ 6 hours, or
  • Donor after circulatory death (DCD) with age ≤ 55 years, or
  • Steatotic liver > 0% and ≤ 40% macrosteatosis at time of retrieval

Donor Exclusion Criteria

  • Living donors
  • Liver intended for split transplants
  • Positive serology (HIV, Hepatitis B surface antigen & Hepatitis C)
  • Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
  • Donor livers with macrosteatosis of > 40% based on retrieval biopsy readout.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT04186221
Other Study ID Numbers  ICMJE OCS-LVR10202019
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 Not Provided
Current Responsible Party TransMedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE TransMedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ahmed Elbetanony, MD TransMedics
PRS Account TransMedics
Verification Date September 2022

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