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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 : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
TransMedics

Brief Summary:
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

Condition or disease Intervention/treatment Phase
Liver Transplant Device: OCS Liver System Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single-arm, continued access protocol
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 3, 2020
Actual Primary Completion Date : February 2, 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Treatment arm Device: OCS Liver System
OCS Liver System for preserving and assessing donor livers for transplantation




Primary Outcome Measures :
  1. Incidence of EAD or primary non-function [ Time Frame: 7 days ]
    Incidence of early allograft dysfunction or primary non-function of donor liver


Secondary Outcome Measures :
  1. OCS donor liver assessment during perfusion [ Time Frame: During OCS perfusion, on average 4 hours ]
    Collection of liver perfusion parameters while on OCS device

  2. Patient Survival at Day 30 post-transplantation [ Time Frame: 30 days ]
    Survival

  3. Patient Survival at initial hospital discharge post liver transplantation [ Time Frame: 30 days ]
    Survival


Other Outcome Measures:
  1. Length of initial post-transplant ICU stay [ Time Frame: ICU days, on average 5 days ]
    ICU stay

  2. Length of initial post-transplant hospital stay [ Time Frame: Hospital days, on average 10 days ]
    Hospital stay

  3. Evidence of ischemic biliary complications diagnosed at 6 and 12 months post transplant [ Time Frame: 6 and 12 months ]
    Ischemic biliary complications

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04186221


Locations
Show Show 17 study locations
Sponsors and Collaborators
TransMedics
Investigators
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Study Director: Ahmed Elbetanony, MD TransMedics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT04186221    
Other Study ID Numbers: OCS-LVR10202019
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: June 2021

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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