OCS Liver PROTECT Continued Access Protocol

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

Tracking Information

• First Submitted Date: November 26, 2019
• First Posted Date: December 4, 2019
• Last Update Posted Date: September 13, 2022
• Actual Study Start Date: February 3, 2020
• Actual Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: OCS Liver PROTECT Continued Access Protocol
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Liver Transplant

Intervention

Device: OCS Liver System

OCS Liver System for preserving and assessing donor livers for transplantation

Study Arms

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 1, 2021): 74
• Original Estimated Enrollment (submitted: December 2, 2019): 184
• Estimated Study Completion Date: February 26, 2023
• Actual Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04186221
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: TransMedics
• Original Responsible Party: Same as current
• Current Study Sponsor: TransMedics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Ahmed Elbetanony, MD; TransMedics

• PRS Account: TransMedics
• Verification Date: September 2022